ANP-10266, Rev. 3, 'AREVA NP Inc. Quality Assurance Plan ... · AREVA NP Inc. Quality Assurance...

ANP-10266 Revision 3

AREVA NP Inc. Quality Assurance Plan (QAP) for

Design Certification of the U.S. EPR™

Topical Report

May, 2011

AREVA NP Inc.

Copyright © 2011 AREVA NP Inc.

All Rights Reserved

Abstract for ANP-10266 AREVA NP Inc. Quality Assurance Plan

For Design Certification of the U.S. EPR™

U.S. EPR™,Design Certification requires a Quality Assurance Plan (QAP) to be

prepared in accordance with 10 CFR 50, Appendix B, NQA-1-1994, and NUREG-0800;

this Topical Report has been prepared to meet the requirements of the aforementioned

standards/regulations. The U.S. EPR™,QAP implements the AREVA Inc. Quality

Assurance Program, 56-9141754; AREVA NP Inc. implementing procedures and

instructions implement the QAP. The Topical Report is divided into eighteen (18)

sections conforming to the requirements noted in 10 CFR 50, Appendix B.

This document describes the Quality Assurance Plan (QAP) for the design certification

of commercial nuclear operating plants, specifically the U.S. EPR™, and for products

and services supplied by AREVA NP Inc. under nuclear safety related criteria.

Addendum A of this Document describes the non-safety related QAP. Further, the QAP

contains the following appendices:

• Appendix A, QA Program Implementing Policies, Procedures, and Instructions

• Appendix B, Regulatory Commitments: Compliance with Applicable Regulatory Guides, Generic Letters, and Standards

• Appendix C, Acronyms, Abbreviations, and Definitions

Appendix A contains a listing of AREVA NP Inc. Polices, Procedures, and Instructions

that implement the U.S. EPR™,QAP. Appendix B details how AREVA NP Inc. is

compliant with applicable Regulatory Guides, Generic Letters, and Standards.

Appendix C is a definitions reference for commonly used terms used in nuclear safety

related Quality Programs.

AREVA NP Inc. ANP-10266 Revision 3

AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page i

Nature of Changes

Revision 03 Item No. Section(s) or Page(s) Description and Justification 1. Title Page Revised revision level and date; 2. Abstract Revised AREVA Inc. QA Program,

added EPR trademark throughout 3. Nature of Changes Re-ordered to have latest revisions

first. Added Revision 3 changes 4. Contents and Nomenclature Revised Page Numbering and section

titles as required. Added additional Acronyms

5. Statement of Policy Updated to current Statement of Policy

6. Section 0.1.3 Revised President and CEO to CEO of AREVA NP Inc. Revised VP, Sustainable Development and Continuous Improvement (SDCI) & Quality to VP, Quality & Performance

6. Section 0.1.4 Revised VP, SDCI & Quality to Quality & Performance

7. Section 1.0, Organization Completely Revised Organization and updated exhibits

8. Section 2.1.3 Revised 56-5015885 to new AREVA Inc. QA Program 56-9141754

9. Sections 2.1.4 and 2.1.5 Revised President and CEO to CEO of AREVA NP Inc. Revised VP, Sustainable Development and Continuous Improvement (SDCI) & Quality to VP, Quality & Performance In last paragraph of 2.1.5, Revised President and CEO to CEO and COO

10. Section 7.4 Corrected grammatical error 11. Section 7.8 Revised VP, SDCI & Quality to VP,

Quality & Performance 12. Appendix A Updated QA Program Implementing

Documents as required 13. Addendum A Revised VP, SDCI & Quality to VP,

Quality & Performance


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page ii

Nature of Changes

Revision 02 Item No. Section(s) or Page(s) Description and Justification 1. Title Page Revised revision level and date;

added copyright notice; omitted “Non-Proprietary”

2. Copyright Page/Disclaimer Page Omitted; copyright notice was added to Title Page; Disclaimer Page no longer necessary

3. Nature of Changes Added Revision 2 changes 4. Contents Revised Page Numbering as

Required. 5. Section 0.1.3 Revised VP, US Region Quality to

VP, Sustainable Development and Continuous Improvement (SDCI) & Quality

6. Section 0.1.4 Revised VP, US Region Quality to VP SDCI & Quality

7. Section 1.0, Organization Updated the organization names and descriptions as required, added revised exhibits 1A and 1B

8. Section 2.1.3 Updated NUREG 0800, SRP 17.5 from draft

9. Sections 2.1.4 and 2.1.5 Revised VP, US Region Quality to VP SDCI & Quality and Organization as applicable

10. Section 5.3.1 Added alternative filing of procedures into the Records Management System

11. Section 7.8 Revised VP, US Region Quality to VP SDCI & Quality

12. Appendix A Updated QA Program Implementing Documents as required

13. Appendix B, 1a Updated Revision of Regulatory Guide 1.26 to Revision 4 to agree with FSAR commitment

14. Appendix B, 1d Updated Revision of Regulatory Guide 1.29 to Revision 4 to agree with FSAR commitment

15. Appendix B, 1f Updated Revision of Regulatory


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page iii

Item No. Section(s) or Page(s) Description and Justification Guide 1.37 to Revision 1 per RAI 38, Question 17.5-1

16. Appendix C-Definitions Corrected definition of Safety Related 17. Addendum A Revised VP, US Region Quality to VP

SDCI & Quality, corrected typo

Nature of Changes Revision 01

Item No. Section(s) or Page(s) Description and Justification 1. Title Page Revised per RAI #1

Revised document number, revision level and date

2. Disclaimer Page and Abstract Revised to provide applicability to Design Certification only and other updates

3. Statement of Policy Added Statement of Policy Page (RAI #5)

4. Nomenclature Added acronym and definition of Purchase Requisition

5. Section 0.0, Introduction Revised per RAIs #1 and #2 6. Section 0.1.4 Revised to update document

issuance and revision requirements 7. Section 0.1.5 Deleted Document Assignments as

not applicable to the Topical Report 8. Section 1.0, Organization Revised per RAIs #1, #3, #4, #6, #7

and #8 Also, updated the organization names and descriptions as required, added exhibits 1A and 1B

9. Section 2.0, Quality Assurance Program

Revised per RAIs # 1, #3, # 4, #9, #10, #11, #12 and #56 Also, updated Section 2.1.3, QAP Requirements

10. Section 3.0, Design Control Revised per RAIs # 1,#3,# 4 #13,#14, #16 and, #17

11. Section 4.0, Procurement Document Control

Revised per RAIs # 1,#3,# 4 Updated Section 4.2.1 to include Purchase Requisition (PR) options and clarify PO use.

12. Section 5.0, Instruction, Procedures and Drawings

Revised per RAIs # 1,#3, #4 and #15

13. Section 6.0, Document Control Revised per RAIs # 1,#3, #4 and #18


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page iv

Item No. Section(s) or Page(s) Description and Justification 14. Section 7.0, Control of Purchased

Materials, items and Services Revised per RAIs #1, #3, #4, #21, #22, #23 and #25

15. Section 8.0, Identification and Control of Items and Materials

Revised per RAIs #1,#3, and #4

16. Section 9.0, Control of Special Processes

Revised per RAIs #1, #3, #4

17. Section 10.0, Inspection Revised per RAIs #1, #3, # 4 18. Section 11.0, Test Control Revised per RAIs #1, #3, # 4, and

#29 19. Section 12.0, Control of Measuring

and Test Equipment Revised per RAIs #1, #3, #4, #30 and #31

20. Section 13.0, Handling, Storage, and Shipping


21. Section 14.0, Inspection, Test, and Operating Status


22. Section 15.0, Control of Nonconforming Items

Revised per RAIs #1, #3, #4, and #38

23. Section 16.0, Corrective Action Revised per RAIs #1, #3, #4, #42 and #43

24. Section 17.0, Quality Assurance Records

Revised per RAIs #1, #3, #4, #44, #45, #46, #47 and #49

25. Section 18.0, Audits Revised per RAIs #1, #3, #4, #48, #50, #51, #52 and #53

26. Appendix A Updated document numbers and titles. Added reference to Procedure 1724-01.

27. Appendix B Regulatory Commitments: Compliance with Applicable Regulatory Guides, Generic Letters and Standards

Revised per RAIs #55 and #56 Also deleted reference to Reg. Guide 1.8.

28. Appendix C Definitions Revised per RAIs #40, #41, #57 and #58 Added definition of Purchase Requisition

29. Addendum A Non-Safety Related Products and Services

Revised per RAI #59 Updated Section A-4.2 Procurement Process to include reference to PR

30. All Sections Corrected miscellaneous typographical errors


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page v

NOTE: The above stated changes are in accordance with 10 CFR 50.54(a)(3). The changes do not reduce the commitments to the quality assurance program description as approved in ANP-10266A, Revision 1.


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page vi

Statement of Policy


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page vii

Contents Page

Nature of Changes ....................................................................................................... iii Statement of Policy ...................................................................................................... vi Contents....................................................................................................................... vii Nomenclature .............................................................................................................. xii 0.0 INTRODUCTION............................................................................................... 0-1

0.1 Purpose .................................................................................................. 0-1 0.1.1 Scope........................................................................................... 0-1 0.1.2 General ........................................................................................ 0-2 0.1.3 Responsibility ............................................................................... 0-2 0.1.4 Document Issuance and Revision................................................ 0-2

1.0 ORGANIZATION............................................................................................... 1-1 1.1 Purpose .................................................................................................. 1-1 1.2 AREVA NP Inc. (Exhibit 1)...................................................................... 1-2 1.3 Reactors and Services (Exhibit 2)........................................................... 1-2 1.4 Engineering and Projects (Exhibit 3)....................................................... 1-2 1.5 Quality and Performance (Exhibit 4) ....................................................... 1-3 1.6 Human Resources (Exhibit 1) ................................................................. 1-4 1.7 Chief Financial Officer (Exhibit 1) ........................................................... 1-4 1.8 Marketing (Exhibit 1) ............................................................................... 1-4 1.9 Legal (Exhibit 1)...................................................................................... 1-5 1.10 Purchasing (Exhibit 1)............................................................................. 1-5 1.11 Information Systems (Exhibit 1) .............................................................. 1-5

2.0 QUALITY ASSURANCE PROGRAM ............................................................... 2-1 2.1 Purpose .................................................................................................. 2-1

2.1.1 Scope........................................................................................... 2-1 2.1.2 General ........................................................................................ 2-1 2.1.3 QAP Requirements ...................................................................... 2-2 2.1.4 QAP Implementation .................................................................... 2-2 2.1.5 QAP Assessment ......................................................................... 2-3 2.1.6 QAP Indoctrination and Training .................................................. 2-4


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page viii

3.0 DESIGN CONTROL .......................................................................................... 3-1 3.1 Purpose .................................................................................................. 3-1

3.2 General ................................................................................................... 3-1

3.3 Implementation ....................................................................................... 3-1

3.4 Design Inputs.......................................................................................... 3-2

3.5 Design Interfaces.................................................................................... 3-3

3.6 Design Verification.................................................................................. 3-3 3.6.1 Independent Review of Design Documents ................................. 3-3 3.6.2 Design Analyses .......................................................................... 3-4 3.6.3 Design Review Boards (DRB)...................................................... 3-4 3.6.4 Design Verification Testing .......................................................... 3-4

3.7 Design Changes ..................................................................................... 3-5

3.8 Engineering Assistance/Advice and Consultation................................... 3-5

4.0 PROCUREMENT DOCUMENT CONTROL ...................................................... 4-1 4.1 General ................................................................................................... 4-2

4.2 Implementation ....................................................................................... 4-2 4.2.1 Procurement Process................................................................... 4-2 4.2.2 Procurement Document Content.................................................. 4-2 4.2.3 Procurement Document Review................................................... 4-3 4.2.4 Changes to Procurement Documents .......................................... 4-3

5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS....................................... 5-1 5.1 Purpose .................................................................................................. 5-1

5.2 General ................................................................................................... 5-1

5.3 Implementation ....................................................................................... 5-2 5.3.1 Administrative Policies, Procedures, and Instructions.................. 5-2 5.3.2 Drawings and Specifications ........................................................ 5-2

6.0 DOCUMENT CONTROL ................................................................................... 6-1 6.1 Purpose .................................................................................................. 6-1

6.2 General ................................................................................................... 6-1

6.3 Implementation ....................................................................................... 6-2 6.3.1 Document Control System ........................................................... 6-2 6.3.2 Document Change Control........................................................... 6-2 6.3.3 Release of Documents................................................................. 6-2 6.3.4 Supplier Prepared Documents ..................................................... 6-2 6.3.5 Customer Prepared Documents................................................... 6-3


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page ix

7.0 CONTROL OF PURCHASED MATERIALS, ITEMS, AND SERVICES............ 7-1 7.1 Purpose .................................................................................................. 7-2

7.2 General ................................................................................................... 7-2

7.3 Supplier Evaluation and Selection .......................................................... 7-2 7.3.1 Dedication of Commercial Grade Items and/or

Services ....................................................................................... 7-3 7.4 Approved Supplier List (ASL).................................................................. 7-4

7.5 Procurement Process Monitoring............................................................ 7-4

7.6 Item/Service Verification ......................................................................... 7-5 7.6.1 Receiving Inspection .................................................................... 7-5

7.7 Supplier Nonconformances..................................................................... 7-5

7.8 Certifications of Conformance (CoC/QA Data Packages)....................... 7-5

8.0 IDENTIFICATION AND CONTROL OF ITEMS AND MATERIALS .................. 8-1 8.1 Purpose .................................................................................................. 8-1

8.2 General ................................................................................................... 8-1

8.3 Implementation ....................................................................................... 8-2

9.0 CONTROL OF SPECIAL PROCESSES ........................................................... 9-1 9.1 Purpose .................................................................................................. 9-1

9.2 General ................................................................................................... 9-1

9.3 Implementation ....................................................................................... 9-1 9.3.1 Welding ........................................................................................ 9-2 9.3.2 Heat Treatment ............................................................................ 9-2 9.3.3 Nondestructive Examination (NDE).............................................. 9-3

10.0 INSPECTION................................................................................................... 10-1 10.1 Purpose ................................................................................................ 10-1

10.2 Scope.................................................................................................... 10-1

10.3 General ................................................................................................. 10-1

10.4 Implementation ..................................................................................... 10-2 10.4.1 Inspection Types ........................................................................ 10-2 10.4.2 Inspection Plan........................................................................... 10-2 10.4.3 Inspection Result........................................................................ 10-2 10.4.4 Review of Completed Inspection Documentation....................... 10-3

11.0 TEST CONTROL............................................................................................. 11-1 11.1 Purpose ................................................................................................ 11-1


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page x

11.2 General ................................................................................................. 11-2

11.3 Implementation ..................................................................................... 11-2

12.0 CONTROL OF MEASURING AND TEST EQUIPMENT................................. 12-1 12.1 Purpose ................................................................................................ 12-1

12.2 General ................................................................................................. 12-1

12.3 Implementation ..................................................................................... 12-2 12.3.1 Procedures................................................................................. 12-2 12.3.2 Control of M&TE......................................................................... 12-2 12.3.3 M&TE Suppliers and M&TE Calibration Services....................... 12-3 12.3.4 Customer Furnished M&TE........................................................ 12-4

13.0 HANDLING, STORAGE, AND SHIPPING ...................................................... 13-1 13.1 Purpose ................................................................................................ 13-1

13.2 General ................................................................................................. 13-1

13.3 Implementation ..................................................................................... 13-2 13.3.1 Cleanliness ................................................................................ 13-2 13.3.2 Storage ...................................................................................... 13-2 13.3.3 Packaging .................................................................................. 13-2 13.3.4 Handling..................................................................................... 13-2 13.3.5 Shipping ..................................................................................... 13-2

14.0 INSPECTION, TEST, AND OPERATING STATUS ........................................ 14-1 14.1 Purpose ................................................................................................ 14-1

14.2 General ................................................................................................. 14-1

14.3 Implementation ..................................................................................... 14-2 14.3.1 Status Indication by Travelers or Manufacturing/Field

Procedures................................................................................. 14-2 14.3.2 Status Indication by Tags........................................................... 14-2

15.0 CONTROL OF NONCONFORMING ITEMS ................................................... 15-1 15.1 Purpose ................................................................................................ 15-1

15.2 General ................................................................................................. 15-1

15.3 Internal Nonconformances.................................................................... 15-2 15.3.1 Nonconformances ...................................................................... 15-2 15.3.2 Safety Concerns......................................................................... 15-3 15.3.3 Audit Findings (AF) .................................................................... 15-3

15.4 Supplier Nonconformances................................................................... 15-3

15.5 Contract Variation Approval Request (CVAR) ...................................... 15-3


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page xi

16.0 CORRECTIVE ACTION .................................................................................. 16-1 16.1 Purpose ................................................................................................ 16-1

16.2 General ................................................................................................. 16-1

16.3 Implementation ..................................................................................... 16-2

17.0 QUALITY ASSURANCE RECORDS .............................................................. 17-1 17.1 Purpose ................................................................................................ 17-1

17.2 General ................................................................................................. 17-1

17.3 Implementation ..................................................................................... 17-3

18.0 AUDITS ........................................................................................................... 18-1 18.1 Purpose ................................................................................................ 18-1

18.2 General ................................................................................................. 18-1

18.3 Internal Audits....................................................................................... 18-2

18.4 Supplier Audits...................................................................................... 18-2

18.5 Audit Reports ........................................................................................ 18-4

APPENDIX A QA Program Implementing Policies, Procedures, and Instructions......................................................................................... A-1

APPENDIX B Regulatory Commitments: Compliance with Applicable Regulatory Guides, Generic Letters, and Standards....................... B-1

APPENDIX C Definitions........................................................................................... C-1

ADDENDUM A Non-Safety Related Products and Services ................................AP-1


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page xii

Nomenclature

Acronym Definition

ADI Applicable Document Index

ADL Applicable Documents List

AF Audit Finding

ANSI American National Standards Institute

ASL Approved Suppliers List

ASME American Society of Mechanical Engineers

CR Condition Report

CFR Code of Federal Regulations

CO Change Order

CoC Certificate of Conformance

CVAR Contract Variation Approval Request

DCF Document Comment Form

DRB Design Review Board

DRN Document Release Notice

FCA Field Change Authorization

HDL Historical Document List

ITAAC

Inspections, Tests, Analyses, and Acceptance Criteria

I&C Instrumentation & Control

I&MC Inspection and Material Control


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page xiii

Acronym Definition

M&TE Measuring & Test Equipment

NDE Non-Destructive Examination

NIAC Nuclear Industry Assessment Committee

NIST National Institute of Standards and Technology

NRC Nuclear Regulatory Commission

OEM Original Equipment Manufacturer

OI Operating Instruction

OOC Out of Commission

PA Purchasing Authorization

PO Purchase Order

POPS Policies and Procedures System

PR Purchase Requisition

PWA Project Work Authorization

QA Quality Assurance

QAP Quality Assurance Plan

QC Quality Control

RDR Receipt Discrepancy Report

RFQ Request for Quote

WI Working Instruction


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page 0-1

0.0 INTRODUCTION

0.1 Purpose

This document describes the Quality Assurance Plan applicable to the Design

Certification of the U.S. EPR. The plan is based on the Eighteen (18) point criteria of 10

CFR 50, Appendix B, and ANSI/ASME NQA-1-1994.

However, the scope of the design certification project does not include fabrication,

erection, installation or operations.

Therefore, this QAP provides the specific applicability and application of the Criteria of

Appendix B and the Basic, Supplemental and applicable Subpart requirements of

ANSI/ASME NQA-1-1994 to the U.S. EPR Design Certification Project.

Each section of this QAP clearly delineates the applicability of the criteria to the U.S.

EPR Design Certification Project.

ASME Boiler and Pressure Vessel Code items are covered under a separate Quality

Assurance Program. Addendum A of this Document describes the non-safety related

QAP.

0.1.1 Scope

The applicable scope and criteria as specified in Sections 1 – 18 of this document is

mandatory for nuclear safety related activities associated with the U.S. EPR Design

Certification Project. Addendum A of this Document describes the requirements for

non-safety related activities. Refer to Appendix C for definitions of safety related and

non-safety related.

This QAP is in compliance with the regulations, codes, standards, and other

requirements listed in Section 2.1.3. Each section of this document provides the

controls in place to accomplish compliance to the applicable criteria specified in each

section. Typical policies, procedures, and instructions which detail how these controls

are implemented are listed in Appendix A.



0.1.2 General

AREVA NP Inc. has primary locations in Lynchburg, Virginia, Charlotte, North Carolina,

and Marlborough, Massachusetts with other satellite offices positioned in the U.S.

0.1.3 Responsibility

The CEO of AREVA NP Inc. has the overall responsibility for the quality of work. The

Vice President, Quality & Performance, is responsible for developing this QAP and for

assuring its proper implementation. All personnel are responsible for implementing this

QAP when performing work.

0.1.4 Document Issuance and Revision

The Vice President, Quality & Performance is responsible for the preparation,

maintenance, and revision of this Document. This document is authorized for use and

shall be fully implemented upon release.

This document will be reviewed once each calendar year by AREVA NP Inc. QA and

revised as necessary to assure that it continues to accurately describe the QAP and any

changes due to regulations, commitments, reorganizations, or program improvements

from continuous review of assessment results and process improvement initiatives. All

revisions will be prepared by QA with input from cognizant, affected department

managers.

Any changes that reduce commitments in the approved QAP will be submitted to the

NRC for review and approval prior to implementation as required by 10 CFR 50.54(a)(3)

and 10 CFR 50.55(f)(3). Changes that do not reduce commitments will be submitted in

accordance with 10 CFR 50.54 and 10 CFR 50.55(f)(3), as applicable.

For the purposes of 10 CFR 50.54(a)(3) and 10 CFR 50.55(f)(3) the following are not

considered a reduction in commitment.

• Quality assurance program changes involving administrative improvements and clarifications, spelling corrections, punctuation, or editorial items



• The use of a QA standard approved by the NRC which is more recent than the QA standard in the licensee’s current QA program at the time of the change

• The use of a quality assurance alternative or exception approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to the licensee’s facility

• The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles

• The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or, alternately, the use of descriptive text

• The elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which the licensee is committed

• Organizational revisions that ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations

Revisions to this document are made by revision of the entire document.

All pages of the revised document shall indicate the new revision level. Changes made

in the revision process are indicated on the nature of changes page.



1.0 ORGANIZATION

Section 1.0, Organization, applies to the Design Certification Project.

This section complies with Criterion I of 10 CFR 50, Appendix B, Organization, and

Basic Requirement 1, Organization and Supplementary Requirements for Organization,

1S-1, of ANSI/ASME NQA-1-1994.

1.1 Purpose

AREVA NP Inc., the Company, is the U.S. Regional Division, wholly owned subsidiary

of AREVA SA that is headquartered in Paris, France. Further, the Company is

organized into five (5) major Business Groups, Business Units, and a resource group as

shown in Exhibit 1. However, for the purposes of this QAP, it is applicable only to the

following organizations:

Reactors and Services U.S., with the exception of Nuclear Measurements

and Equipment Engineering and Projects resource group U.S. U.S. Support Functions such as Quality and Performance, Human

Resources, Information Systems, Finance, Legal, Marketing, and Purchasing.

The Company’s QAP covers all nuclear safety related activities associated with the

design and deployment of commercial nuclear power plants, specifically US EPR™ ,

and products and services supplied by these groups for the US EPR™.

It is the responsibility of management to ensure that personnel affecting quality related

activities are qualified in accordance with written procedures.

AREVA NP Inc. management is responsible to ensure that the size of the Quality

Assurance organization is commensurate with the duties and responsibilities assigned.



The functions and responsibilities of the organizations of the Company which operate

under and implement the QAP are described as follows:

1.2 AREVA NP Inc. (Exhibit 1)

The CEO of AREVA NP Inc. is responsible for the management of the Company’s

nuclear energy products and services, energy management, and energy market

systems in the U.S. The portfolio includes solutions for renewable energy and expertise

in all aspects of the nuclear fuel cycle, including reactor design and construction. The

Business Groups and Units participating in this QAP are depicted in Exhibit 1.

1.3 Reactors and Services (Exhibit 2)

The Reactors and Services U.S. Business Group Senior Executive Vice President

reports to the CEO of AREVA NP Inc. and to the Reactors and Services Executive in

France. The organization specializes in the design, construction, and servicing of

pressurized water reactors (PWRs), boiling water reactors (BWRs), and research

reactors, as well as in the manufacture of radiation detection and analysis

instrumentation

1.4 Engineering and Projects (Exhibit 3)

The Engineering and Projects Senior Executive Vice President reports to the CEO of

AREVA NP Inc and to the Engineering and Projects Executive in France. The

Engineering & Projects organization provides design, construction and commissioning,

inspection and project management services exclusively for the AREVA

nuclear Business Groups.



1.5 Quality and Performance (Exhibit 4)

The Vice President of Quality and Performance reports to the CEO of AREVA NP Inc.

Company policy dictates that the Vice President of Quality and Performance is

responsible for preparation, implementation, and maintenance of this QAP.

Organizational freedom and independence from the activities being regulated is

ensured by providing the Vice President of Quality and Performance with access to the

Senior Executives, Vice Presidents, managers of the regulated activities, and to the

CEO of AREVA NP Inc.

The reporting structure provides sufficient authority for Quality and Performance

personnel to:

Identify quality problems,

Initiate, recommend, or provide solutions through designated channels,

Verify implementation of solutions,

Suspend or control further processing or delivery of nonconforming items until proper

disposition of the identified deficiency has been approved and documented.

Responsibility for the control of further processing, delivery, installation, or operation of

nonconforming items shall be designated in writing.

The Manager of Quality Programs reports to the Vice President of Quality and

Performance; the function is responsible for the implementation and maintenance of this

QAP and the ASME Section III and XI Quality Assurance Program. The group is also

responsible for the implementation and maintenance of the Corrective Action Program.

The Manager of Quality Programs is also responsible for managing the Internal,

Supplier, and Customer Audits Programs for the activities covered by this QAP.



The Manager of Quality Operations also reports to the Vice President Quality and

Performance and is responsible for ensuring compliance with codes and standards in

the preparation and execution of projects, project support, qualification of inspection and

surveillance personnel, and supplier oversight planning.

The Manager of Records Management also reports to the Manager Quality and

Performance. The Records Management function is responsible for duplication,

storage, and retention of quality related records.

1.6 Human Resources (Exhibit 1)

The Vice President of Human Resources U.S. reports to the CEO of AREVA NP Inc.

and to the Human Resources Executive in France. This group supports the AREVA

Business Groups in the U.S. by assisting with all personnel actions, such as

recruitment, hiring, promotion, training, compensation, benefits, and termination.

1.7 Chief Financial Officer (Exhibit 1)

The AREVA Inc. Vice President, Chief Financial Officer (CFO), and Treasurer reports to

the CEO of AREVA NP Inc and to the Finance Executive in France. The mission of this

organization is to coordinate financial management operations and suggest

recommendations for the improvement of the group's financial performance.

1.8 Marketing (Exhibit 1)

The Vice President of Marketing reports to the CEO of AREVA NP Inc. and to the

Marketing Executive in France. The organization has the overall responsibility for

business marketing for the Company.



1.9 Legal (Exhibit 1)

The Chief Legal Director reports to the CEO of AREVA NP Inc and to the Legal

Executive in France. This function provides legal assistance and support to the AREVA

Business Groups in the U.S.

1.10 Purchasing (Exhibit 1)

The Vice President of Purchasing reports to the CEO of AREVA NP Inc. and to the

Purchasing Executive in France. The purchasing function is responsible for providing

the company with a competitive advantage through proactive supplier development and

management of an effective, flexible and reliable supply chain. This function is

responsible for all safety related procurements made in the U.S.

1.11 Information Systems (Exhibit 1)

The Vice President of Information Systems reports to the CEO of AREVA NP Inc. and to

the Information Systems Executive in France. The function supports AREVA NP Inc.

and the Business Groups with data management and communication.



EXHIBIT 1

CEOAREVA NP Inc.

MiningU.S.

Back End U.S.

Transnuclear

Recycling

MOX

Renewables U.S.

ADAGE

Wind

Solar

Front End U.S.

Fuel

AREVAEnrichment

Services

Reactors & Services U.S.

Installed Base*New BuildsEquipment*

Products and Tech.*Nuclear Measure-

ment

Engineering and Projects

AREVA U.S. Organization AREVA U.S. Support OrganizationsGvt. Affairs Finance HR Legal Marketing Strategy Purchasing Communication Information Systems Quality and PI SDCI

AREVA Federal Services FE Sales

*IBB Sales includes sales for these BUs



EXHIBIT 2

Installed Base

New Builds

Product & Technology

Equipment

Nuclear Measurements

Installed BaseNorth America

New BuildsNorth America

Product & TechnologyNorth America

EquipmentNorth America

Nuclear MeasurementsNorth America

HR Quality Finance

Legal I.S. Communications

SupportFunctions

SupportFunctions

SupportFunctions

SupportFunctions

SupportFunctions

Communications

Legal

HRExecutive Assistants

R&S BG

R&S BG SUPPORT FUNCTIONS

R&S BG

Performance Improvement

Installed Base

New Builds

Product & Technology

Equipment

Nuclear Measurements

Installed BaseNorth America

New BuildsNorth America

Product & TechnologyNorth America

EquipmentNorth America

Nuclear MeasurementsNorth America

HR Quality Finance

Legal I.S. Communications

SupportFunctions

SupportFunctions

SupportFunctions

SupportFunctions

SupportFunctions

Communications

Legal

HRExecutive Assistants

R&S BG

R&S BG SUPPORT FUNCTIONS

R&S BG

Performance Improvement



EXHIBIT 3

Construction & Commissioning

Planning & Footprint Strategy

Internal Communication

Project Operations

Human Resources

Finance

Quality

Processes, Methods & Tools

Design

Engineering & Projects Organization

Executive Assistant

Process, Methods & Tools

Design Engineering

E&PNorth America

Project Management

Project Management

Construction & Commissioning

Project Operations

Planning &Footprint Strategy

Programs & Internal Communications

Quality

Finance

Human Resources

SDCISDCI



EXHIBIT 4

Quality & PerformanceQuality & Performance

PerformanceImprovement


Quality ProgramsQuality Programs

Support FunctionsAREVA Group

Executive AssistantExecutive Assistant

D3SED3SE

TrainingTraining

Quality & Performance Organization

PerformanceImprovementPerformanceImprovement

EH&S EH&S

Training ProgramsTraining Programs


Regulatory AffairsRegulatory Affairs

Records Mgmt Records Mgmt

Quality OperationsQuality Operations

Access ControlAccess Control

Global OrganizationsQ&P

Quality & PerformanceQuality & Performance




Support FunctionsAREVA Group

Executive AssistantExecutive Assistant

D3SED3SE

TrainingTraining

Quality & Performance Organization

PerformanceImprovementPerformanceImprovement

EH&S EH&S

Training ProgramsTraining Programs


Regulatory AffairsRegulatory Affairs

Records Mgmt Records Mgmt

Quality OperationsQuality Operations

Access ControlAccess Control

Global OrganizationsQ&P

AREVA NP Inc. ANP-10266 Revision 3 AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page 2-1

2.0 QUALITY ASSURANCE PROGRAM

The Quality Assurance Program, as specified in each section of the QAP, applies to the

Design Certification Project.

This section complies with Criterion II of 10 CFR 50, Appendix B, Quality Assurance

Program, and Basic Requirement 2, Quality Assurance Program, and the following

supplemental requirements of ANSI/ASME NQA-1-1994:

• 2S-1, Supplementary Requirements for the Qualification of Test and Inspection Personnel

• 2S-2, Supplementary Requirements for the Qualification of Nondestructive Examination Personnel

• 2S-3, Supplementary Requirements for the Qualification of Quality Assurance Program Audit Personnel

• 2S-4, Supplementary Requirements for Personnel Indoctrination and Training

2.1 Purpose

This section defines the QAP implemented by AREVA NP Inc. for nuclear safety related

activities, specifically the U.S. EPR.

2.1.1 Scope

The QAP establishes the prerequisites for achieving quality, such as the need for

specialized equipment and skills, use of suitable administrative, process, and

environmental controls, training and indoctrination of personnel performing activities

affecting quality, and the need for verification of quality by reviews, inspection,

examination, and test. The QAP assures that activities affecting quality are

accomplished under suitably controlled conditions. It also provides for the development,

control, and use of computer programs.

2.1.2 General

AREVA NP Inc. has established and implemented procedures which provide

requirements and guidelines for establishing the safety classification of systems,


structures, and components (SSC), and for determining the quality group classification,

applicable quality standards, and the seismic design classification, applicable quality

standards, and the seismic design classification of SSCs commensurate with their

respective safety classification.

Structures, systems and components important to safety are designed, fabricated,

erected and tested to quality standards commensurate with the importance of the safety

functions to be performed. Where generally recognized codes and standards are used,

they are justified and evaluated to determine their applicability, and supplemented or

modified as necessary to assure a quality product in keeping with required safety

functions.

2.1.3 QAP Requirements

This QAP is organized and administered to comply with:

• 10 CFR 50, Appendix A, General Design Criteria 1(a), Appendix B, 50:55(a), and 50:55(b)

• 10 CFR 21

• 10 CFR 50.34(f)(3)(iii)(A), (C), (H)

• Quality Assurance related to NRC Regulatory Guides, Generic Letter commitments and other standards as described in Appendix B of this Document

• ANSI/ASME NQA-1-1994, Basic and Supplemental Requirements and applicable subparts

• NUREG 0800, SRP 17.5, Quality Assurance Program Description-Design Certification, Early Site Permit and New Licensee Applicants as applicable to Design Certification

• 56-9141754, AREVA Inc. Quality Assurance Program

• Other quality requirements as may be imposed by contract

2.1.4 QAP Implementation

This QAP establishes and maintains standards of quality through the development and

use of quality engineering and manufacturing practices, which are documented by


written policies, procedures, and instructions. These policies, procedures, and

instructions are controlled as described in Section 5 and 6 of this QAP; they have been

coordinated with and are mandatory for each of the applicable groups within AREVA NP

Inc.

Typical policies, quality assurance plans, procedures, and instructions that implement

this QAP are referenced in Appendix A. AREVA NP Inc. may add, modify, and/or delete

the referenced policies, procedures, and instructions without changing the intent of the

QAP. Therefore, the document references should only be considered as

representative; these references will be updated as necessary during subsequent

revisions of this document. If required by contract, customer originated procedures may

be used to implement this QAP provided their use is defined in contract unique Project

Management Documents or QA Plans which have been approved by the CEO of

AREVA NP Inc. (or designee), the AREVA NP Inc. Vice President, Quality &

Performance, and the responsible project management function.

A QAP may be prepared as needed to address the application of a contract which

implies a departure from the general requirements of this QAP; a QAP may also be

prepared to address the application of a contract which implies additional processes

without departure from the general requirements of this QAP.

QA personnel are charged with escalating to the Vice President, Quality & Performance,

for resolution, any quality related problems that cannot be resolved at their level. In

turn, the Vice President, Quality & Performance will escalate to the CEO of AREVA NP

Inc. any quality related problem that cannot be resolved.

2.1.5 QAP Assessment

Assessments of the scope, status, adequacy, and compliance of this QAP with

Appendix B of 10 CFR 50, NQA-1, and other QAP commitments, such as 10 CFR 21,

are performed by AREVA NP Inc. staff management in several ways. The Vice


President, Quality & Performance evaluates this document once every calendar year

and updates to incorporate any administrative or operational changes necessary to

ensure that it accurately describes the QAP. When changes are desired, the affected

staff managers shall provide the Vice President, Quality & Performance input as to the

status, adequacy, and effectiveness of that part of the QAP for which they have been

designated responsibility. In addition, at the direction of the Vice President, Quality &

Performance, qualified auditors perform an independent audit of the Quality &

Performance organizations implementation of the QAP once each calendar year. The

results of these audits are provided to the CEO of AREVA NP Inc., the Vice President,

Quality & Performance, and the Quality Managers.

The CEO of AREVA NP Inc. periodically conducts staff meetings where each staff

manager presents the status of activities within his group and any problems that require

resolutions by AREVA NP Inc. management. In addition, written monthly reports are

made by each staff manager describing their significant activities and problems during

the month. The CEO of AREVA NP Inc. receives copies of the results of internal audits

performed by the Quality & Performance Organization.

The CEO and COO of AREVA NP Inc., through customer feedback, personal

observations, staff meetings, monthly reports, and audit reports, assures himself of the

adequacy and effectiveness of this QAP and implementing procedures.

2.1.6 QAP Indoctrination and Training

2.1.6.1 AREVA NP Inc. Personnel

Indoctrination and training requirements of this QAP are provided to all personnel

engaged in activities covered by this QAP. This indoctrination and training is conducted

in accordance with written procedures and includes instruction as to the purpose,

scope, and implementation of the quality related documents, policies, procedures, and

instructions.


2.1.6.2 AREVA NP Inc. QA/QC Personnel

In addition to the indoctrination and training described above, personnel performing

inspection, surveillance, and audit activities are qualified. This qualification is

conducted and documented in accordance with the applicable requirements listed in

Section 2.1.3 of this QAP.


3.0 DESIGN CONTROL

Section 3.0, Design Control, applies to the Design Certification Project.

This section complies with Criterion III of 10 CFR 50, Appendix B, Design Control, and

Basic Requirement 3, Design Control, and the following supplemental requirements and

Subparts of ANSI/ASME NQA-1-1994:

• 3S-1, Supplementary Requirements for Design Control

• 11S-2, Supplementary Requirements for Computer Program Testing

Computer Software utilized for safety-related design analysis also complies with

Subpart 2.7, Quality Assurance Requirements of Computer Software for Nuclear Facility

Applications.

3.1 Purpose

This section describes the method used to provide control of design, design verification,

and analysis activities.

3.2 General

AREVA NP Inc. maintains design control during the performance of work activities

associated with this QAP. The project management function establishes in writing to

the responsible design organizations the scope, objectives, requirements, and safety

classification. When design review boards are required, the requirement is identified by

the responsible technical manager with concurrence of the responsible project

management function.

3.3 Implementation

Design control measures are applied to safety related items and services as defined in

written procedures and instructions.

These design control measures are implemented through procedures which include the

provisions for the control of design inputs, processes, outputs, verification, independent


review, analysis, verification testing, design changes, organizational interfaces within

AREVA NP Inc. and with suppliers, records and QA reviews.

AREVA NP Inc. has established and implements a process to control the design and

design changes of items that are subject to the provisions of this QAP. These

provisions assure that design inputs (such as design bases and the performance,

regulatory, quality, and quality verification requirements) are correctly translated into

design outputs (such as analyses, specifications, drawings, procedures, and

instructions) so that the final design output can be related to the design input in

sufficient detail to permit verification.

The design control program includes interface controls necessary to control the

development, verification, approval, release, status, distribution and revision of design

inputs and outputs. Design changes are reviewed and approved by the AREVA NP Inc.

design organization.

3.4 Design Inputs

Procedures have been established for the preparation and review of design documents.

Design inputs, e.g., the design bases, performance and regulatory requirements and

codes and standards, are correctly translated into design outputs, e.g., specifications,

drawings, procedures, and instructions.

The appropriate engineering organization is responsible for the preparation, review,

approval, and verification of design documents for items and services within the

respective area of responsibility. Design documents include such documents as plant

technical requirements, system design requirements, system descriptions, design

drawings, design analyses, computer program documentation, specifications and

procedures. These documents specify technical and quality requirements appropriate

to the activities they cover, and are independently reviewed for completeness and

technical accuracy. AREVA NP Inc. design records are maintained to provide evidence

that the design supports the facility design, construction and operations and that the


design was properly accomplished. Records include not only the final design output

and revisions to the final output, but also the important design steps (e.g., calculations,

analyses, and computer programs) and the sources of input that support the final

output.

Revisions to design documents are subject to the same review and approval process as

the original documents.

QA provides an overview during audits of design documents, such as drawings and

specifications used as procurement documents or as manufacturing requirements for

the inclusion of appropriate QA requirements. Deviations from specified quality

standards are identified and controlled in accordance with written procedures.

3.5 Design Interfaces

Procedures establish methods for the identification and control of design interfaces, for

coordination among participating design organizations, and for review, approval,

release, distribution, and revision of documents.

The project management function and responsible technical management establishes

design interfaces.

3.6 Design Verification

Procedures are established to assure adequacy and accuracy of designs. Verification

methods include independent review of design documents, design analyses

(calculations), design review boards, and design verification testing. The design

organization determines design verification methods to be used.

3.6.1 Independent Review of Design Documents

All design documents are independently reviewed for completeness and technical

accuracy by a technically qualified individual other than the preparer of the document.


Design documents are reviewed by individuals knowledgeable and trained in QA and

qualified to ensure the documents contain the necessary QA requirements.

In certain instances, the reviewer may be the preparer’s supervisor or manager as

explained in AREVA NP Inc.’s position on Regulatory Guides 1.28 and 1.64 contained

in Appendix B.

3.6.2 Design Analyses

Design analyses (calculations) are used to establish design requirements or to verify the

design. The analyst is required to document the calculations as to purpose,

assumptions, method, design input data, results, and conclusions in such a manner that

an independent reviewer can verify its technical accuracy. Design analyses are

checked by independent reviewers who are competent in the particular type of analysis.

Computer programs used for design analyses are certified or verified and validated as

appropriate.

3.6.3 Design Review Boards (DRB)

Design Review Boards (DRB) are conducted in accordance with written procedures for

new designs and major changes to existing designs as determined by the responsible

technical manager and project management functions.

A DRB verifies the adequacy of a design by assuring that it is based on sound technical

principles and that it meets specified requirements. DRB’s may be conducted at the

conceptual, preliminary, and/or final design stages.

Results of DRB’s are documented and the responsible technical manager must resolve

DRB comments, as necessary, to close out the DRB.

3.6.4 Design Verification Testing

Design verification by testing is used whenever engineering judgment leads to the

conclusion that design analyses or previous experience cannot substantiate a design or


design feature. Verification testing is incorporated using written test procedures which

incorporate the requirements of the design documents that establish the design limits of

the items or features being tested.

If verification of a design or design feature is solely by test, the testing is conducted

under the most adverse design conditions as determined by analysis. Test results are

reviewed by the responsible technical manager to determine if they verify the design or

design feature(s) tested.

3.7 Design Changes

Design changes, including field changes, are subject to the same design controls and

levels of review as were applicable to the original design. Such changes are

documented, reviewed, approved and incorporated into the design documents as

described in AREVA NP Inc. written procedures. Where a significant design change is

necessary because of an incorrect design, the design process and verification

procedure is reviewed and modified as necessary.

3.8 Engineering Assistance/Advice and Consultation

Certain aspects of AREVA NP Inc. work may include providing engineering manpower

assistance or advice and consultation services at a location designated by a customer.

In such circumstance, the work will be performed under the provisions of the customer’s

QAP unless otherwise authorized by contract.


4.0 PROCUREMENT DOCUMENT CONTROL

This section defines procurement document control for safety related items and

services.

For the Design Certification Project, the scope of procurement includes engineering,

design and testing services as well as the procurement of safety-related software. No

equipment or components are being procured as part of the Design Certification Project.

Plant Sector AREVA NP Inc. affiliate companies such as AREVA NP SAS, AREVA NP

GmbH and the AREVA NP Plants Technical Centers, as well as cross sector affiliates

such as the AREVA NP Nuclear Fuel or Jeumont SA are considered suppliers.

Procurement activities with these internal interfacing organizations as well as any

external organizations providing safety-related products or services are conducted in

accordance with Procurement Document Control requirements.

Each organization utilized has been evaluated in accordance with QAP requirements

and maintained on the AREVA NP Inc. Plants and Services Approved Suppliers List.

This section complies with Criterion IV of 10 CFR 50, Appendix B, Procurement

Document Control, and Basic Requirement 4, Procurement Document Control, and the

following supplemental requirements of ANSI/ASME NQA-1-1994 :

4S-1, Supplementary Requirements for Procurement Document Control with the

following clarifications and exceptions:

• Section 2.3 of supplement 4S-1 includes a requirement that procurement documents require suppliers to have a documented QAP that implements NQA-1-1994, Part 1. In lieu of this requirement, AREVA NP Inc. may require suppliers to have a documented supplier QAP that is determined to meet the applicable requirements of 10 CFR 50, Appendix B, as appropriate to the circumstances of the procurement.

• With regard to service performed by the supplier, AREVA NP Inc. procurement documents may allow the supplier to work under the AREVA NP Inc. QA Program, including implementing procedures, in lieu of the supplier having its own QAP.


4.1 General

Applicable design bases and other requirements necessary to assure adequate quality

shall be included or referenced in documents for procurement of items and services.

4.2 Implementation

4.2.1 Procurement Process

The technical, manufacturing, quality, regulatory, administrative, reporting, and other

requirements prescribed in drawings, specifications, and other documents are

transferred into procurement documents by inclusion in or reference on Purchasing

Authorizations (PA)/Purchase Requisitions (PR). Technical requirements are specified

in the attachments listed on the PA/PR. PA’s/PR’s are prepared, reviewed, and

approved as stipulated in procurement procedures.

The project management function is authorized to procure items and services directly

from other AREVA NP Inc. organizations using a PA as the contract with these

organizations.

Orders placed with external suppliers are processed though AREVA NP Inc.’s

purchasing organization. Purchasing converts the PA/PR into a Purchase Order (PO)

or Change Order (CO). The PO/CO is then sent to the supplier.

QA reviews procurement documents to ensure correct documentation of acceptable

quality requirements, and to determine the need for QA hold/witness points and

surveillance activities.

4.2.2 Procurement Document Content

Procurement documents include or reference the following information and

requirements, as applicable:

• Scope – statement of the work to be performed

• Technical requirements – drawings, specifications, codes, standards, regulations, procedures, instructions, test and inspection requirements and equipment,


acceptance criteria, and special process instructions for such activities as: fabrication, inspection, cleaning, packaging, handling, shipping, and storage

• Documentation Requirements – identification of supplier documents and records to be prepared, maintained, submitted, and made available for AREVA NP Inc.’s review and/or approval

• QA requirements – identification of quality requirements imposed on the supplier

• Source inspection and audit – identification of source inspection and audit requirements including the right of access to the supplier’s facilities and records, and any sub-tier suppliers

• Sub-tier Procurements – extension of applicable procurement document requirements to lower tier suppliers. AREVA NP Inc. may require the supplier to use a sub-supplier from the AREVA NP Inc. Approved Supplier List (ASL).

• Nonconformances – requirements for supplier reporting of nonconformances, and AREVA NP Inc. approval of nonconformances

• Date of submission

4.2.3 Procurement Document Review

Procedures are established for the review of procurement documents by AREVA NP

Inc. QA to determine the quality requirements are correctly stated, inspectable, and

controllable, that there are adequate acceptance and rejection criteria, that the

procurement documents have been prepared, reviewed, and approved in accordance

with QAP requirements, and that the supplier has been evaluated as specified in

Section 7 of this QAP.

AREVA NP Inc. QA has the responsibility and authority to order termination or

suspension of procurement activities when procurement documents conflict with the

requirements of the QAP. Such orders will indicate the action to be taken to allow

resumption or reinstatement of the procurement activity.

4.2.4 Changes to Procurement Documents

Changes to procurement documents are processed in the same manner as the original

procurement documents.

Processing and approval of a supplier nonconformance that deviates from the

procurement document requirements is described in Section 15 of this QAP.


Changes made as a result of the bid evaluations or pre-contract negotiations are

incorporated into the procurement documents. The review of such changes and their

effects are completed prior to contract award. Reviews are performed by Purchasing

personnel who have access to the pertinent information and who have an adequate

understanding of the requirements and intent of the procurement documents.


5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS

Section 5.0, Instructions, Procedures and Drawings applies to the Design Certification

Project.

This section complies with Criterion V of 10 CFR 50, Appendix B, Instructions,

Procedures and Drawings, and Basic Requirement 5, Instructions, Procedures and

Drawings of ANSI/ASME NQA-1-1994.

5.1 Purpose

This section defines the controls established by the Company for the control of

procedures, instructions, and drawings that prescribe activities affecting quality.

5.2 General

Measures are established and documented to assure that activities affecting the quality

of items are established in instructions, procedures, or drawings, and accomplished in

accordance with these documents. Instructions, procedures, and drawings shall be

prepared, reviewed, approved, and distributed before beginning the activity.

AREVA NP Inc. QA personnel are included in the documented review and concurrence

of quality-related procedures associated with design, construction and installation.

Instructions and procedures may include the following items, as required:

• Activities falling within the scope of the document,

• Individuals, organizations, or functions who perform the activities,

• Sequencing to aid in the performance of complex activities, and,

• Quantitative and qualitative acceptance criteria (or references which contain the criteria) to determine the satisfactory accomplishment of defined activities.


5.3 Implementation

5.3.1 Administrative Policies, Procedures, and Instructions

The QAP is implemented through this document, and administrative policies,

procedures, and instructions. Policies provide written guidance for the control of

activities and operations of AREVA NP Inc. Administrative procedures, including

Engineering Guidelines, are documents that specify or describe how activities or

operations are performed within AREVA NP Inc. Working Instructions (WI) are on the

same level hierarchically as administrative procedures in function. Operating

Instructions (OI) may be used to describe how activities or operations are performed

within a department.

Approved policies and procedures are filed on the AREVA NP Inc. Intranet website on

Policies and Procedures System (POPS), at Manual Stations, and distributed to others

electronically by Records Management. Alternatively, procedures and other approved

documents may be filed in the AREVA NP Inc.’s Record Management System.

Approved instructions are controlled, distributed, and maintained current by the issuing

organization.

5.3.2 Drawings and Specifications

Drawings and specifications are released for use in engineering, procurement,

manufacturing, and field activities as described in Section 6 of this QAP.


6.0 DOCUMENT CONTROL

Section 6.0, Document Control, applies to the Design Certification Project.

This section complies with Criterion VI of 10 CFR 50, Appendix B, Document Control

and Basic Requirement 6, Document Control, and the following supplemental

requirements of ANSI/ASME NQA-1-1994:

• 6S-1, Supplementary Requirements for Document Control

6.1 Purpose

This section defines the system of controls for the preparation, review, approval,

revision, distribution, and use of documents that prescribe activities affecting quality.

6.2 General

Company procedures and instructions detail the methods for preparation, review,

approval, revision, distribution, and use of documents. In addition, procedures govern

the coordination and control of interface documents. Interface documents may include

those between engineering disciplines, engineering projects, affiliate companies,

suppliers, or customers.

The following types of documents are controlled within the document control system:

• Quality Documents – includes administrative documents, AREVA NP Inc. QAP’s, nonconformance documents, and procedures describing activities affecting quality (refer to Sections 0, 5 and 15 of this QAP)

• Design Documents – includes calculations, drawings, specifications, analyses, computer codes, and documents related to software (refer to Sections 3 and 5 of this QAP)

• Technical Documents – includes inspection, field, test, and special processes procedures and documents (refer to Sections 5, 9, and 11 of this QAP)

• Procurement Documents (refer to Section 4 of this QAP)

• Manufacturing Documents (refer to Sections 5, 9 and 11 of this QAP)

• Construction Documents (refer to Sections 5, 8, 9, and 11 of this QAP)


6.3 Implementation

6.3.1 Document Control System

Measures are established to assure that documents are reviewed for adequacy and

approved for release by authorized personnel to individuals and locations requiring the

documents for work activity. The document control function also provides for the

following:

• Updating Policies and Procedures System (POPS – Intranet site which contains implementing documents), master document lists, control logs, or other means used to identify the current status and revision level of documents

• Accumulating, protecting, and storing AREVA NP Inc., supplier, or customer documentation

• Coordinating and controlling interface documents

6.3.2 Document Change Control

Changes and revisions to the documents listed in Section 6.1 shall have at least the

same review and approval as the original document. If the original organization no

longer exists or is no longer responsible, another qualified organization may approve

changes and revisions.

6.3.3 Release of Documents

Documents such as drawings, specifications, and calculations are released using

Document Release Notices (DRN), or Applicable Document Lists (ADL). DRN’s and

ADL’s are prepared and approved by designating personnel as prescribed by

administrative procedures. Computer programs are released for use upon completion

of their certification process as defined in procedures. Superseded documents are

controlled by Records Management. Documents are distributed to and used by

personnel performing quality related work.

6.3.4 Supplier Prepared Documents

Documents prepared by suppliers (drawings, design reports, procedures, etc.) are

received by Purchasing or the project management function.


The reviewer prepares a Document Comment Form (DCF) indicating the review status

of the document. A document number is obtained from the applicable AREVA NP Inc.’s

Records Management database by the document owner. If the document is not

approved, it is returned to the supplier with an explanation of corrections to be made.

If the document is approved, it is sent to the customer for review and approval when

required by contract.

Resolved customer comments are sent to the supplier for document revision.

6.3.5 Customer Prepared Documents

For customer originated documents, the cognizant engineer records the comments in a

memo and forwards it to the customer via the project management function. On

approval of the document, a DCF is prepared by the cognizant engineer and released to

Records Management for entry into the Contract Documents List.


7.0 CONTROL OF PURCHASED MATERIALS, ITEMS, AND SERVICES

The scope of procurement for the Design Certification Project includes engineering,

design and testing services, as well as the procurement of safety-related software. No

equipment or components are being procured as part of the Design Certification Project.

Therefore, for the Design Certification Project, the controls associated with this section

apply to the control of the applicable services only.

This section complies with Criterion VII of 10 CFR 50, Appendix B, Control of

Purchased Material, Equipment and Services and Basic Requirement 7, Control of

Purchased Items and Services, and the following supplemental requirements of

ANSI/ASME NQA-1-1994:

• 7S-1, Supplementary Requirements for Control of Purchased Items and Services with the following clarifications and exceptions: - AREVA NP Inc. considers that the Authorized Nuclear Inspection Agencies,

National Institute of Standards and Technology, or other State and Federal agencies which may provide items or services are not required to be evaluated or audited.

- When purchasing commercial grade calibration services from a calibration laboratory, procurement source evaluation and selection measures need not be performed provided each of the following conditions are met: (1) The purchase documents impose any additional technical and

administrative requirements, as necessary, to comply with the AREVA NP Inc. QA program and technical provisions. At a minimum, the purchase document shall require that the calibration certificate/report include identification of the laboratory equipment/standard used.

(2) The purchase documents require reporting as-found calibration data when calibrated items are found to be out-of-tolerance.

(3) A documented review of the supplier's accreditation shall be performed and shall include a verification of each of the following:

• The calibration laboratory holds a domestic Accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP) or by the American Association for Laboratory Accreditation (A2LA) as recognized by NVLAP through the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA).


• The accreditation is based on ANS/ISO/IEC 17025.

• The published scope of accreditation for the calibration laboratory covers the necessary measurement parameters, ranges, and uncertainties.

7.1 Purpose

This section governs the control of purchased safety related materials, items, and

services including source evaluation and selection, source inspection, and receiving

inspection in accordance with regulatory and contract requirements.

7.2 General

The control of purchased safety related materials, items, and services are in

accordance with written procedures and instructions. AREVA NP Inc. QA audits the

capability of suppliers of safety related materials, items, and services and maintains a

list of approved suppliers.

7.3 Supplier Evaluation and Selection

The acceptability of suppliers of safety related materials, items, or services are based

on the following items:

• A direct evaluation of their QA Program to 10 CFR 50 Appendix B and NQA-1 to determine the capability to supply materials, items, or services meeting all procurement document requirements

• A survey/audit of the supplier’s facility

Suppliers are required to ensure that their products meet the requirements of the

procurement documents. These methods are reviewed by the cognizant

Manager/Supervisor with an overview by the QA organization. Additionally, AREVA NP

Inc. may verify acceptance of products by independent analysis.

The AREVA NP Inc. acceptance of products by independent analysis is applicable only

to the suppliers of ASME materials from suppliers that have not been audited by

AREVA NP Inc. but who hold ASME Certificates. AREVA NP Inc. would conduct

independent analysis prior to acceptance of the material. This method is not applicable


to the Design Certification as no materials are being procured in the scope of the

project.

Reviews of the vendor quality program, performance of audits, performance of pre-

award evaluations and annual evaluations are performed in accordance with an

administrative procedure which follows the guidance of Regulatory Guide 1.28 and

1.144; these methods are used to verify the quality of the products and services

provided by subcontractors/sub-vendors. As part of this program subcontractors/sub-

vendors are required to furnish documents such as QA Data Packages, procedures,

source audit and surveillance reports, and QAP documents. Sub-vendor/subcontractor

QAP’s are reviewed and accepted during the pre-award evaluation of the sub-vendor/

subcontractor prior to placement on the Approved Suppliers Listing (ASL).

Suppliers passing an audit by an AREVA NP Inc. affiliate may be accepted by QA as a

supplier of safety related materials, items, and/or services. QA will review the audit

checklist, auditor qualifications, and audit reports to assure conformance with AREVA

NP Inc. requirements. A copy of the audit report, audit checklist, resolution to any

deficiencies, and auditor qualification is maintained in the QA audit files.

QA also participates in a shared audit program through the Nuclear Industry

Assessment Committee (NIAC). NIAC shares the results of supplier audits among

industry companies, reducing the supplier’s number of external audits. Audit checklists,

auditor qualifications, resolution to any deficiencies, and audit reports are reviewed to

assure conformance to AREVA NP Inc. requirements.

7.3.1 Dedication of Commercial Grade Items and/or Services

Commercial grade items and/or services for safety related applications may be procured

from suppliers where specific quality controls for nuclear applications cannot be

imposed in a practical manner. In these instances, an evaluation of the suitability of the

item or service for nuclear applications is performed by the responsible technical


manager and quality organization. The critical characteristics of the item or service are

also determined and documented as part of this evaluation. Special methods shall be

established by the responsible technical manager and quality organization to provide

assurance that the item or service specified is the item or service received. If needed,

these special quality verification methods may include inspections, tests, commercial

grade surveys, or evaluations of the supplier. Suppliers of commercial grade items

and/or services need not appear on the ASL.

7.4 Approved Supplier List (ASL)

Procedures control the maintenance of the ASL. Suppliers meeting the criteria

described in Section 7.3 are included in the ASL issued by the Manager of Quality

Audits and Programs for safety related items and services.

Procurement selects suppliers from this list for placement of orders that impose safety

related requirements and are capable of providing the types of items/services in

accordance with the requirements of the procurement documents. With Project

Management and QA approval, suppliers not on the ASL may be selected in situations

where unique products or services are needed. These suppliers may be utilized, as

described above, provided work is conducted under applicable portions of the AREVA

NP Inc. QA program at the supplier’s location and provided AREVA NP Inc. Quality

performs 100% surveillance of the supplier’s activities. Requirements to perform

surveillance are determined by QA and/or the responsible technical manager.

On an individual basis and at the direction of the customer, AREVA NP Inc. will use a

customer approved supplier; however, the supplier will not be placed on the ASL.

Suppliers of items and/or services remain on this list as long as they maintain

acceptable quality performance standards and they continue to satisfy the audit criteria.

7.5 Procurement Process Monitoring

Procurement documents are reviewed by QA as described in Section 4 of this QAP.


7.6 Item/Service Verification

Source inspections or surveillances are performed as required by the written criteria of

the procurement documents. The inspection/surveillance requirements in the

procurement documents indicate the AREVA NP Inc. inspection, witness, and/or hold

points, as well as any customer designated hold and/or witness points.

7.6.1 Receiving Inspection

Incoming items received by AREVA NP Inc. at its own facilities or at a plant site for use

in safety related applications undergo receiving inspection by inspection personnel prior

to the release of such items for further processing. Receipt inspectors shall perform

receipt inspections of material in accordance with Working and Operating Instructions to

ensure compliance with procurement documents. Receiving inspections may be

conducted on an individual item or sampling basis.

Concurrent with the receiving inspection, QA verifies that all supplier documentation

required by the procurement documents has been reviewed by the appropriate

organizations for completeness and compliance with requirements. The inspection

status of accepted items and material is identified per Section 8.

7.7 Supplier Nonconformances

Nonconformances detected during an inspection or surveillance are processed in

accordance with Section 15.3 of this QAP. The inspection report notes

nonconformances dispositioned as repair or use-as-is. The supplier submits a written

request to AREVA NP Inc. for disposition approval as required by Section 15.4 of this

QAP.

7.8 Certifications of Conformance (CoC/QA Data Packages)

For items designed by AREVA NP Inc. and manufactured within AREVA NP Inc. or by

suppliers, the project management function furnishes the customer with a QA Data

Package that provides objective evidence that the materials and items meet the

requirements of the customer’s order. As a minimum, the QA Data Package consists of


a CoC signed by the responsible QA representative. Other supporting documentation

may be included as required by the customer’s order.

CoC’s for the assembly, repair, modification, or testing of safety related items are

processed as described in written procedures. AREVA NP Inc. procedures for QA Data

Packages and CoCs contain provisions that establish the minimum acceptable list of

criteria for documentary evidence that items and/or services procured from suppliers or

from within AREVA NP Inc. conform to procurement document requirements and that

those criteria are provided on the CoC. As a minimum, a stand alone CoC details and

attests to the following, if applicable:

• Customer/ Plant Site

• AREVA NP Inc. QADP package number

• Customer PO Number and Change Order Number

• AREVA NP Inc. Contract No.

• Item identification

• Description of item or service provided

• Technical Documents

• Equipment Code Class and reference made to AREVA NP Inc. Certificate (for ASME supplied materials only)

• Applicable QA program identification and revision number

• Non-Conformances or exceptions to PO

• Non-conformances resolved

• Revision of CoC and description of revision

• General statements of compliance to applicable codes, standards, tests and quality assurance requirements

• Acceptance signature by AREVA NP Inc. Quality Representative (for ASME and safety related CoC only)

CoC’s are signed by the Vice President, Quality & Performance or designee.


8.0 IDENTIFICATION AND CONTROL OF ITEMS AND MATERIALS

Based on the types of procurements previously stated for the Design Certification

Project, the scope of the project does not include the identification and control of

material, parts and components.

This element is therefore not applicable to the Design Certification Project.

However, this section does comply with Criterion VIII of 10 CFR 50, Appendix B,

Identification and Control of Materials, Parts and Components and Basic Requirement

8, Identification and Control of Items, and the following supplemental requirements of


• 8S-1, Supplementary Requirements for Identification and Control of Items

8.1 Purpose

This section defines the measures used to ensure the preparation and use of written

procedures for identification and control of safety related materials and items, and to

ensure that only correct and accepted items are used or installed.

8.2 General

Procedures are established by AREVA NP Inc. for the identification and control of items

to assure that:

• Only correct and accepted items are used. Nonconforming items are identified and segregated from acceptable items.

• Identification and traceability of items is maintained from receipt through storage, processing, and assembly to final acceptance of complete items.

• Correct identification of items is verified and documented prior to release for fabrication, assembly, or shipment.

• Identification of items can be traced to applicable documentation such as drawings, specifications, procurement documents, manufacturing and inspection documents, nonconformance reports, and mechanical and chemical test reports.


• Items are identified by heat number, part number, serial number, lot number, or other unique identifiers as applicable, either on the item or on records traceable to the item.

• Identification methods used are not detrimental to the item.

• Physical identification is used whenever possible. Where physical identification is either impractical or insufficient, physical separation, procedural controls, or other means are employed.

• Identification markings are transferred to each piece or lot prior to subdivision.

Specific identification such as task, group, sequence numbers, or part numbers are

assigned as applicable by the responsible AREVA NP Inc. organizations to safety

related items supplied by AREVA NP Inc. These numbers are used to identify the items

and for the association of documents to the items for which they are applicable.

8.3 Implementation

The identification of items manufactured by AREVA NP Inc. is established using the

identification requirements contained in drawings, specifications, customer orders,

and/or internal procedures. Control and traceability are maintained by procedures

covering the manufacturing, inspection, and field operations in accordance with the

requirements of Section 8.2 of this QAP. Suppliers may use the AREVA NP Inc.

assigned identification numbers in conjunction with their own identification system

during design, procurement, fabrication and shipping. Suppliers using their own

identification and control systems must be able to demonstrate traceability to the

AREVA NP Inc. assigned identification number.


9.0 CONTROL OF SPECIAL PROCESSES

The scope of the design certification project does not include fabrication, erection,

installation or use.


However, this section complies with Criterion IX of 10 CFR 50, Appendix B, Control of

Special Processes and Basic Requirement 9, Control of Processes, and the following


• 9S-1, Supplementary Requirements for Control of Processes

9.1 Purpose

This section defines the manner in which AREVA NP Inc. ensures that procedures are

established and used to control special processes for safety related items.

9.2 General

Special processes include but are not limited to welding, heat treating, and

nondestructive examination (NDE). Cleaning is considered to be a special process with

exceptional and unusual care in cleaning is necessary as defined in the applicable

drawings and specifications. Written procedures establish the requirements for the

control of special processes used by AREVA NP Inc.

9.3 Implementation

Special processes may be subcontracted to qualified suppliers (refer to Sections 4 and

7) or performed by AREVA NP Inc.

AREVA NP Inc. special processes are controlled to ensure the following:

• Special processes are performed in accordance with qualified, approved procedures using approved methods and materials, utilizing personnel and equipment qualified in accordance with applicable codes and/or standards.

• Records of procedures, processes, operators, and equipment qualifications and approvals are maintained and available for review.


• Special processes are accomplished with written process sheets, shop procedures, checklists, travelers, computerized tracking, or equivalent that provide adequate methodologies for recording evidence of verification.

9.3.1 Welding

Written procedures or instructions govern the methods used to qualify welding

procedures and personnel in accordance with applicable codes and standards. The

cognizant welding engineer is responsible for the qualification of welding procedures,

welders, and welding operators.

After qualification, welding procedures are released for use as described in Section 6 of

this QAP. In addition, they are released for specific applications by reference in

travelers, fabrication routing documents, manufacturing procedures, or field procedures

as discussed in Section 6 of this QAP.

The assignment of qualified welders and welding operators to specific jobs is the

responsibility of the welding supervisors. The welding supervisors assure that the

specified welding procedures are available, that the welding personnel are properly

qualified, and that welding is performed as specified in written procedures or

instructions.

All welded joints are traceable to the welder(s) or welding operators who performed the

welding operations via at least one of these methods: traveler, manufacturing

procedure, field procedure, or weld control record. The initiating and dating of the

traveler, fabrication routing document, or procedures (at the appropriate sequences)

and the weld control record by welding personnel or welding supervisor provides this

traceability.

9.3.2 Heat Treatment

Heat treatment of base material and welds is subcontracted to qualified personnel or

may be performed by AREVA NP Inc. (refer to Sections 4 and 7).


Preheat, interpass, and post weld heat temperature requirements for welding processes

performed are specified in the welding procedures discussed in Sections 9.3.1 of this

QAP.

Post-weld heat treatments performed by AREVA NP Inc. are controlled by procedures

prepared by the responsible engineering organization. These procedures are released

for use as described in Section 6 of this QAP. In addition, they are released for specific

AREVA NP Inc. shop or field applications by reference in travelers, manufacturing

procedures, or field procedures as discussed in Section 5 of this QAP.

9.3.3 Nondestructive Examination (NDE)

9.3.3.1 NDE Personnel Qualification

Personnel performing NDE are qualified to written practices (applicable NDE Personnel

Qualification Procedure) in accordance with the ASME Code and SNT-TC-1A/CP-189

(latest version accepted by the ASME Code) by the appropriate Company NDE

Certification Administrator. Records of personnel qualification including the Level III

certifications are maintained by AREVA NP Inc. NDE Services.

NDE personnel and equipment may be contracted from AREVA NP Inc. approved NDE

suppliers.

9.3.3.2 NDE Procedures

NDE procedures used by AREVA NP Inc. in the examination of items are reviewed and

approved by an appropriate AREVA NP Inc. Level III and are qualified by demonstrating

that the technique detailed in the procedure is capable of detecting the targeted

discontinuities.

NDE procedures are released for use as described in Section 6 of this QAP. They are

released for specific AREVA NP Inc. shop or field applications by reference in travelers,


fabrication routing documents, manufacturing procedures, or field procedures as

described in Section 5 of this QAP.

The results of nondestructive examinations, as required by the applicable codes and

standards, are recorded on inspection records or other related documents as defined in

written procedures or instructions.


10.0 INSPECTION

The scope of the Design Certification Project does not include fabrication, erection,

installation or use. No equipment or components are being procured as part of the



However, this section complies with Criterion X of 10 CFR 50, Appendix B, Inspection,

and Basic Requirement 10, Inspection, and the following supplemental requirements of


• 10S-1, Supplementary Requirements for Inspection

10.1 Purpose

This section establishes the elements of the QAP required for inspection activities

affecting safety related items.

10.2 Scope

This section applies to all safety related items requiring inspection. Inspections required

to verify conformance of an item or activity to specified requirements shall be planned

and executed. For Nondestructive Examination (NDE) inspections, refer to Section 9.

10.3 General

Inspections shall be performed by qualified personnel in accordance with standards and

AREVA NP Inc. written procedures. Inspection personnel are independent from the

individual or group performing the activity being inspected. Inspection procedures,

applicable drawings, travelers, and specifications define inspection criteria, identify

mandatory inspection hold and witness points, and verify acceptable calibration

equipment status. Inspection results are documented, evaluated, and accepted based

on the acceptance criteria specified in the applicable document.


10.4 Implementation

10.4.1 Inspection Types

Source and receiving inspections are covered in Section 7 of this QAP.

In-process and final inspections are, when necessary, performed in accordance with

instructions, procedures, drawings, checklists, travelers, or other appropriate means.

Inspection requirements may also be identified in surveillance requirement documents

or procurement specifications for AREVA NP Inc. or suppliers’ shops and to designate

customer hold or witness points.

10.4.2 Inspection Plan

Planning for inspection activities shall be accomplished and documented. The

documentation shall identify characteristics, methods, and acceptance criteria, and shall

provide for recording objective evidence of inspection results.

Indirect control (by monitoring processing methods, equipment and personnel), is

provided when direct inspection of processed items is impractical or dangerous. Both

inspections and process monitoring are provided when control is inadequate without

both.

10.4.3 Inspection Result

Inspection records include the following information: identification of item inspected,

date, inspection, type of observation, results, acceptability, and reference to actions

taken on nonconformances. An inspector’s initials (or signature) and date at the

inspection sequence on the traveler, in the manufacturing/field procedure, or the

surveillance/QC inspection report, with the item’s status (accepted or rejected), are

used to document the results of inspections. Inspection status is discussed in Section

14 of this QAP and used by inspection personnel to verify completion of the inspection

operations. Nonconforming conditions require completion of a Condition Report (CR)

as described in Section 15 of this QAP.


10.4.4 Review of Completed Inspection Documentation

QA reviews completed inspection documents and verifies the following information: all

sequences were properly certified and signed off, Condition Reports were reviewed,

dispositioned, and resolved, and required inspections were documented.


11.0 TEST CONTROL



Testing and test control associated with proof tests prior to installation, preoperational

tests, and operational tests during plant operations are therefore not applicable to the


Test Control is applicable to tests and testing programs associated with design

verification of the EPR. Tests may be conducted by AREVA NP Inc. or by qualified,

approved suppliers. The requirements for such tests are included in test requirements

documents prepared by the responsible technical manager. These test requirement

documents include, as appropriate, the requirements of this section of the QAP, scope

of the test, technical requirements, and QA requirements.

Computer programs used for design analyses are certified or verified and validated as

required. Computer Program Testing is addresses in Section 3, Design Control, of the

QAP.

This section complies with Criterion XI of 10 CFR 50, Appendix B, Test Control, and

Basic Requirement 11, Test Control, and the following supplemental requirements of


• 11S-1, Supplementary Requirements for Test Control

• 11S-2, Supplementary Requirements for Computer Program Testing

11.1 Purpose

This section applies to the testing of safety related items that are required to

demonstrate compliance with regulatory and contract requirements.


11.2 General

When engineering judgment, codes, standards, regulations, or specifications indicate

that testing is required, a written test program is established via test requirement

documents by the responsible technical manager to ensure conformance with those

requirements. In those cases where design is the responsibility of the AREVA NP Inc.

suppliers, the requirements for written test programs are imposed on those suppliers

through procurement documents.

The test program describes required tests, such as prototype qualification tests or

design verification tests, to demonstrate that the item will perform satisfactorily in

service. Whenever engineering judgment leads to the conclusion that design analysis

or previous experience cannot substantiate a design or design feature, design

verification testing is conducted as described in this section and Section 3.6 of this

QAP.

11.3 Implementation

Tests may be conducted by AREVA NP Inc. or by qualified, approved suppliers. The

requirements for such tests are included in test requirements documents prepared by

the responsible technical manager. These test requirement documents include, as

appropriate, the requirements of this section, scope of the test, technical requirements,

and QA requirements.

The test requirement documents require testing to be performed in accordance with

written test plans and/or procedures that incorporate or reference the design

requirements and acceptance limits contained in the applicable design documents. The

test plans and/or procedures for tests performed by AREVA NP Inc. are prepared by the

responsible technical manager and those for tests at suppliers are prepared by the

supplier and approved by the responsible technical manager as defined in Section 6 of

this QAP.

These plans or procedures provide instructions for performing the test(s) and include

provisions for ensuring that prerequisites for the given tests are complied with, hold and


witness points are included, testing methods are provided, acceptance and rejection

criteria is defined, adequate and calibrated instrumentation is used, testing is performed

under suitable environmental conditions by trained personnel, necessary monitoring is

performed, and provisions are provided for data acquisition, collection and storage.

Test results are documented, evaluated, and their acceptability determined by the

responsible technical manager to ensure that the test requirements have been met.

Test records, at a minimum, identify the item tested, date of test, tester or data recorder,

type of observations, results and acceptability, action taken in connection with any

deviations noted, and person evaluating test results.


12.0 CONTROL OF MEASURING AND TEST EQUIPMENT



The control of M&TE associated with proof tests prior to installation, preoperational

tests, and operational tests during plant operations is therefore not applicable to the


However, the control of M&TE associated with tests and testing programs utilized for

design verification of the EPR are applicable to the project and to organizations that

have conducted such tests.

This section complies with Criterion XII of 10 CFR 50, Appendix B, Control of Measuring

and Test Equipment, and Basic Requirement 12, Control of Measuring and Test

Equipment, and the following supplemental requirements of ANSI/ASME NQA-1-1994:

12S-1, Supplementary Requirements for Control of Measuring and Test Equipment with

the following clarifications and exceptions:

• The out of tolerance conditions described in paragraph 3.2 of supplement 12S-1 refers to when the Measuring and Test Equipment (M&TE) is found out of the required accuracy limits. (i.e., out of tolerance) during calibration.

• M&TE are not required to be marked with a calibration status where it is impossible or impractical due to equipment size or configuration (such as the label will interfere with operation of the device) provided the required information is maintained in suitable documentation traceable to the device.

12.1 Purpose

This section establishes the elements of measuring and test equipment (M&TE) control

as required by regulatory requirements.

12.2 General

Measures are established and documented to assure that tools, gages, instruments,

and other M&TE used in construction, fabrication, testing, examination, or inspection


activities affecting quality are of the range, type, and accuracy to verify conformance to

established requirements. These measures are based upon the requirements of MIL-

STD 45662A, “Calibration System Requirements,” and ANSI/NCSL Z540-1, “Calibration

Laboratories and M&TE General Requirements.”

12.3 Implementation

12.3.1 Procedures

Calibration procedures are prepared to define the method of calibration, means of

identification, recalibration frequency, reference and transfer standards, and recall of

subject or damaged M&TE. Calibration procedures are prepared to define the method

of calibration, means of identification, recalibration frequency, reference and transfer

standards, and recall of subject or damaged M&TE. Calibration procedures are further

prepared to assure M&TE are calibrated and adjusted at prescribed intervals or prior to

use against certified equipment having known valid relationships to nationally

recognized standards. If no nationally recognized standards exist, the bases for

calibration are documented.

Procedures concerning suspect M&TE are also generated to describe removal from

service, methods for tagging and segregating, and requirements for recalibration. If the

M&TE is found to be out of tolerance, an evaluation of previous inspection or test results

shall be performed and documented to determine the acceptability of items inspected

and tested using the defective equipment.

12.3.2 Control of M&TE

M&TE is controlled through an identification system traceable to calibration records.

Calibration records indicate the last calibration date and the due date. The calibration

due date is displayed on or attached to each piece of M&TE or on records traceable to

each item. These calibration requirements do not imply a need for special calibration

and control measures of rulers, tape measures, levels, and other devices where


commercial accuracy is adequate. These devices shall be visually inspected to assure

that damage or deterioration has not impaired their accuracy.

Reference standards are either marked with calibration labels to indicate the next due

date for calibration, or the calibration information is contained in records traceable to the

reference standard.

User organizations shall be responsible for assuring that M&TE used in activities

affecting quality are properly controlled and calibrated to maintain accuracy within

necessary limits. User organizations shall also assure that proper procedures are

followed for gages, measuring devices, and inspection fixtures used to verify and certify

item conformance with specified requirements. Production tooling or fixtures used as

an acceptance inspection method are also subject to the M&TE control program.

12.3.3 M&TE Suppliers and M&TE Calibration Services

Suppliers of M&TE and calibration services for M&TE and reference standards are

required by the procurement documents to have an effective system for the calibration

of M&TE. Suppliers of calibration services used to calibrate M&TE or reference

standards are audited and approved by AREVA NP Inc. QA as described in Sections 7

and 18 of this QAP. State and federal agencies such as the National Institute of

Standards and Technology (NIST) are exempted from this requirement. Other

methods, such as NAVLAP and A2LA, may be used to approve M&TE suppliers

provided the following conditions are satisfied:

For procurement of commercial-grade calibration services for safety-related

applications, laboratory accreditation programs administered by the National Institute of

Standards and Technology and by the American Association for Laboratory

Accreditation, as recognized through the mutual recognition arrangement of the

International Laboratory Accreditation Program (ILAC), are acceptable in lieu of a


supplier audit, commercial-grade survey, or in-process surveillance provided that all of

the following conditions are met:

a. The alternative method is documented in the QA program description. b. Accreditation is to ANSI/ISO/IEC 17025, "General Requirements for the

Competence of Testing and Calibration Laboratories." c. Use of the alternative method is limited to the National Voluntary

Accreditation Program and the American Association for Laboratory Accreditation, as recognized by ILAC signatories.

d. The scope of the accreditation covers the contracted services. e. Purchase documents impose additional technical and administrative

requirements to satisfy necessary QA program and technical requirements. f. Purchase documents require reporting as-found calibration data when

calibrated items are found to be out-of-tolerance. g. Purchase documents require identification of the laboratory

equipment/standards used. h. The alternative method is limited to the domestic calibration service suppliers.

The alternative method is applicable to subsuppliers of calibration service suppliers,

provided the above conditions are met.

Alternatively, the acceptability of calibration services performed by an unaudited

supplier may be confirmed/verified by performing surveillance while the item is being

calibrated. The supplier must show traceability to NIST or to a nationally recognized

standard when no NIST standard exists. If the supplier finds the item to be within

calibration, then the item is acceptable for use. The calibration is documented by

AREVA NP Inc. QA/QC; the supplier does not need to be audited by AREVA NP Inc.

QA.

12.3.4 Customer Furnished M&TE

Customer furnished M&TE may be used by AREVA NP Inc. in performing

measurements/tests provided that the customer provides written authorization and

supplies a copy of the calibration certification.


13.0 HANDLING, STORAGE, AND SHIPPING




However, this section complies with Criterion XIII of 10 CFR 50, Appendix B, Handling,

Storage and Shipping, and Basic Requirement 13, Handling, Storage and Shipping and

the following supplemental requirements and subparts of ANSI/ASME NQA-1-1994:

• 13S-1, Supplementary Requirements for Handling, Storage and Shipping

The following subparts apply to scopes of work provided at plant sites or AREVA NP

Inc. facilities. (These subparts do not apply to the scope of the Design Certification

Project)

• Subpart 2.1, “Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components for Nuclear Power Plants”

• Subpart 2.2, “Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage, and Handling of Items for Nuclear Power Plants”

• Subpart 2.15, “Quality Assurance Requirements for Hoisting, Rigging, and Transporting Items for Nuclear Power Plants”

13.1 Purpose

This section describes the methods for handling, storing, and shipping safety related

items.

13.2 General

Operations concerning special handling, storage, cleaning, packaging, and shipping

requirements shall be in accordance with AREVA NP Inc. procedures. These

procedures shall contain accepted practices to prevent damage or deterioration of

components. Special protective environments, such as inert gas atmospheres, specific

moisture content levels, and temperature levels are specified and provided, as

necessary. Customer and supplier specified requirements shall be used as a basis for

AREVA NP Inc. handling, storage, and protection requirements.


13.3 Implementation

13.3.1 Cleanliness

Cleaning operations at AREVA NP Inc. divisions are performed by appropriately trained

personnel in accordance with written procedures which incorporate the requirements of

applicable standards, drawings, or specifications. Measures are taken during

fabrication and storage to preclude damage, loss, or deterioration.

Final assembly operations are performed in areas which permit the attainment of the

final cleanliness level specified in the applicable drawings and specifications. After

completing final inspections, the cleanliness of accepted items is maintained to ensure

compliance with the applicable cleanliness requirements.

13.3.2 Storage

Acceptable items are tagged and placed, as necessary, in designated storage areas.

Items in long term storage areas are periodically inspected for damage to the item or its

packaging.

13.3.3 Packaging

Packaging of acceptable items for shipment from AREVA NP Inc. divisions is performed

as required by the applicable drawings or specifications.

13.3.4 Handling

Major items are handled in such a manner as to preclude damage. Handling devices

used for lifting or transporting major items must undergo periodic load test as prescribed

in written procedures.

13.3.5 Shipping

Items shall be transported according to the proper protection classification and

packaging methods.


14.0 INSPECTION, TEST, AND OPERATING STATUS




This section complies with Criterion XIV of 10 CFR 50, Appendix B, Inspection, Test

and Operating Status and Basic Requirement 14, Inspection, Test, and Operating

Status, of ANSI/ASME NQA-1-1994.

14.1 Purpose

This section defines methods ensuring that measures are taken to indicate the

inspection, test, and operation status of safety related items.

14.2 General

Systems are established and implemented via AREVA NP Inc. procedures for the

control of inspection, test, and operating status of items. The systems contain

provisions for:

• Documenting and identifying items that have satisfactorily passed required inspections and tests

• Precluding inadvertent bypassing of inspection and test requirements

• Providing inspection and test status indicators such as stamps, tags, labels, route cards, and shop travelers

• Controlling the application and removal of status indicators and identifying the source of authority required for such actions

• Controlling and documenting the bypassing of required inspections, tests, or other critical operations when dictated by circumstances

• Ensuring that personnel concerned with production or cost control will not exercise control over the application or removal of status indicators


14.3 Implementation

14.3.1 Status Indication by Travelers or Manufacturing/Field Procedures

The status of fabrication, assembly, inspection, test or field operations for items

processed by AREVA NP Inc. at its facilities or in the field are indicated on travelers or

in manufacturing/field procedures.

Inspection sign-offs on travelers, fabrication routing documents, or manufacturing/field

procedures are as described in Section 10 of this QAP. Inspectors also verify that

operations subsequent to the last inspection operation have been properly initialed and

completed.

Completed travelers, fabrication routing documents, or manufacturing/field procedures

are reviewed by QA as specified in Section 10 of this QAP.

14.3.2 Status Indication by Tags

Tags are attached, as described in AREVA NP Inc. instructions and procedures, by the

inspector(s) to items or their containers indicating successful completion of receipt or

final inspection. Items not in compliance and rejected items are tagged and segregated

from conforming items. Items found to be acceptable during in-process inspection are

noted on the traveler, fabrication routing document, or manufacturing/field procedure

and tags are not used.


15.0 CONTROL OF NONCONFORMING ITEMS



Nonconforming materials, parts, or components are not applicable to the Design

Certification Project.

Nonconformities associated with services or documentation are processed in

accordance with this section of the QAP under the AREVA NP Inc. Corrective Action

Program.

This section complies with Criterion XV of 10 CFR 50, Appendix B, Nonconforming

Materials, Parts, or Components, and Basic Requirement 15, Control of Nonconforming

Items, and the following supplemental requirements of ANSI/ASME NQA-1-1994:

• 15S-1, Supplementary Requirements for the Control of Nonconforming Items

15.1 Purpose

This section applies to safety related materials and items, and their supporting

documentation. It addresses characteristics, documentation, or procedure deficiencies

that render an item or activity unacceptable or indeterminate.

15.2 General

Measures are established to control documentation and items that do not conform to

specified requirements. Specific requirements include procedures for controlling the

identification, documentation, and segregation of nonconforming items pending

notification of affected individuals and/or organizations, review of the nonconformance,

and approval of disposition. Internal and external Condition Report dispositions are

submitted for customer approval as required by the contract or purchase order.


15.3 Internal Nonconformances

Certain nonconformances may be generated with AREVA NP Inc. as a result of

inspections, internal audits, customer audits, customer problems/complaints, or other

deficiencies. These nonconformances are documented and resolved through the use of

the following reports:

15.3.1 Nonconformances

Nonconforming items detected during receiving, in-process, or final inspections at

AREVA NP Inc. facilities or in the field are tagged as described in Section 14 and

documented on a Condition Report (CR).

Personnel performing evaluations to determine a disposition have demonstrated

competence in the specific area they are evaluating, have an adequate understanding

of the requirements, and have access to pertinent background information.

Condition Reports are submitted as necessary to the responsible engineering

organization for review and determination of cause, corrective action, and disposition.

Disposition and subsequent actions may be rework, repair, use-as-is, or scrap and

replace. Definitions of rework, repair, and scrap are contained in Appendix C.

Rework/repair activities are performed in accordance with approved methods or

procedures and re-inspected to the original criteria or to criteria established for the

acceptability of rework or repair.

Condition Reports are issued also when a significant condition adverse to quality exists,

a quality deficiency is recurring and/or where other means of obtaining corrective action

have proved ineffective in resolving a problem; these Condition Reports are considered

a Significance Level 1 or 2. Level 1 and 2 Conditions Reports are used to emphasize

that the cause of a problem be determined and action taken to preclude its recurrence.


15.3.2 Safety Concerns

Nonconformances which may constitute potential significant deficiencies or substantial

safety hazards are processed as preliminary safety concerns in accordance with written

procedures. Safety concerns are processed to the requirements of 10 CFR 21.

15.3.3 Audit Findings (AF)

Internal and external audits may result in audit findings as described in Section 18 of

this QAP.

15.4 Supplier Nonconformances

Supplier nonconformances enter the AREVA NP Inc. system in one of three ways:

• By the submittal of a written request by a supplier for approval of nonconformances that violate requirements of AREVA NP Inc. procurement documents or AREVA NP Inc. approved supplier drawings, specifications, or procedures and the supplier wishes to repair the nonconforming item or use-as-is. This request takes the form of a Contract Variation Approval Request (CVAR) as described in Section 15.5 of this QAP

• By audit findings initiated by QA to identify nonconformances found during supplier audits as described in Section 18 of this QAP

• By Condition Reports issued by quality representatives to document nonconformances detected during source inspection or surveillance as described in Section 7 of this QAP

15.5 Contract Variation Approval Request (CVAR)

CVAR’s may result from supplier nonconformances as discussed in Section 15.4 of this

QAP. The CVAR (or equivalent supplier document) is prepared by the supplier and

includes the determination of cause, corrective action, and recommended disposition,

i.e., repair or use-as-is. Repair dispositions must be accompanied with a repair

procedure or indicate the repair will be performed in accordance with an AREVA NP Inc.

approved repair procedure. The supplier transmits the CVAR to AREVA NP Inc. for

evaluation by the responsible technical manager.

CVAR’s which affect interface, function, or interchangeability are evaluated by the

responsible engineer. CVAR’s which affect these parameters are also evaluated by the


project management function for possible notification to the customer or submittal for

acceptance as prescribed in the customer’s contract.

AREVA NP Inc.’s disposition of a CVAR may be either approved or disapproved.

Approval of use-as-is dispositions must be justified by the responsible technical

manager either by attaching to or referencing on the CVAR such justification.

Disapproved CVAR’s may indicate the reasons for disapproval or alternate dispositions.

Upon receipt of the dispositioned CVAR, the supplier will initiate appropriate actions

consistent with the AREVA NP Inc. disposition.

The dispositioned CVAR is entered into the Records Management System and returned

to the supplier.


16.0 CORRECTIVE ACTION

Section 16.0, Corrective Action is applicable to the design certification project.

This section complies with Criterion XVI of 10 CFR 50, Appendix B, Corrective Action,

and Basic Requirement 16, Corrective Action, of ANSI/ASME NQA-1-1994.

16.1 Purpose

This section defines the elements of the corrective action generation, implementation

and verification system for safety related items or services.

16.2 General

Procedures are established by AREVA NP Inc. to ensure prompt identification and

correction of conditions adverse to quality, such as failures, malfunctions, deficiencies,

deviations, defective material and equipment, and nonconformances during the design,

procurement, fabrication, inspection, and testing of items. These procedures require

the cognizant function assure that:

• All personnel have the responsibility of reporting and/or recording known or identified conditions adverse to quality.

• Nonconformances and failures are evaluated to determine the need for corrective action, and that such action is taken as necessary.

• The cause of the nonconformance or failure is determined and action is taken to preclude recurrence.

• Appropriate levels of management are informed of significant conditions adverse to quality, the cause of the conditions, the corrective action taken, and the preventive action taken to preclude recurrence.

Follow-up is conducted to verify proper implementation of both corrective and

preventive actions and to close out the corrective action documentation.

Responsibilities within the Corrective Action program are not delegated. AREVA NP

Inc. maintains responsibility for the program’s effectiveness.


16.3 Implementation

Condition Reports are generated/received by AREVA NP Inc. as described in Section

15 of this QAP. They are analyzed by QA to determine whether more extensive actions

are required in addition to any corrective action applied to the specific nonconformance.

The stated cause of the nonconformance is reviewed by QA to determine the following:

• Whether there have been previous occurrences,

• Whether the root cause may result in subsequent nonconformances if not corrected,

• Whether the cause indicates a defect or a correctable trend in design, fabrication, processing, personnel training, etc.

• Potential problems identified by QA’s review are reported to the responsible organization for further corrective action. Subsequent review and follow-up is accomplished by QA to determine the effectiveness of the corrective action taken.


17.0 QUALITY ASSURANCE RECORDS

Section 17.0, Quality Assurance Records, applies to the Design Certification Project.

This section complies with Criterion XVII of 10 CFR 50, Appendix B, Quality Assurance

Records, and Basic Requirement 17, Quality Assurance Records and the following


• 17S-1, Supplementary Requirements for Quality Assurance Records

The AREVA NP Inc. Records Management System also implements the requirements

of the following:

• Nuclear Information and Records Management Association, Inc. (NIRMA) Technical Guide (TG) 11-1998, “Authentication of Records and Media”

• NIRMA TG 15-1998, “Management of Electronic Records”

• NIRMA TG 16-1998, “Software Configuration Management and Quality Assurance”

• NIRMA TG 21-1998, “Electronic Records Protection and Restoration”

• Regulatory Issues Summary (RIS) 2000-18, “Guidance on Managing QA Records in Electronic Media.”

17.1 Purpose

This section defines the requirements for the collection, retention and retrievability of

QA records for safety related items or services.

17.2 General

AREVA NP Inc. procedures are established to provide requirements and responsibilities

for document access, user privileges, records generation, identification, transmittal,

retention, and maintenance including design documentation and records not only for the

final design documents, such as drawings and specifications, and revisions thereto, but

also documentation which identifies the important steps, including sources of design

input that support the final design.


Scheduled inspections, surveillances or audits of the program software applications and

media are performed that ensure electronic records retrievability, integrity and retention

periods and meet the guidance provided in Regulatory Issue Summary 2000-18.

QA records are filed and maintained for the durations defined in the Corporate Records

Management Manual 1E1.

The AREVA NP Inc. records management program does not meet the requirements of

NRC Generic Letter 88-18 for the storage of electronic media on optical discs. The

AREVA NP Inc. records management program is written and implemented to satisfy the

guidance provided in RIS 2000-18 and NIRMA Technical Guidelines TG-11, TG-15, TG-

16 and TG-21.

This records program meets or exceeds the requirements of ANSI N45.2.9 (Reg. Guide

1.88). QA records include the following documents:

• Procurement Documents

• Procedures and Instructions

• Drawings

• Specifications

• Design Analysis Calculations and Review

• Contract Agreements

• Audit Records (internal and external)

• Personnel Qualifications

• Inspection and Test Records

• Nonconformance Records

• Corrective Action Records

• Receiving Inspection Records


17.3 Implementation

Records Management maintains and controls QA records generated by AREVA NP Inc.

and/or submitted by suppliers/customers. Records Management procedures provide

record identification and control, and address protection and retrieval of records to

prevent deterioration, damage, or loss.

Documents being entered into the records management system are examined for

adequacy, legibility and completeness.

Entities not located near the home office will submit QA records to Records

Management on a frequency determined in appropriate procedures.

At the completion of a contract, the QA records for the contract will be stored by AREVA

NP Inc. and/or provided to the customer as specified in the contractual agreements.


18.0 AUDITS

Section 18, Audits, applies to the design certification project.

This section complies with Criterion XVIII of 10 CFR 50, Appendix B, Audits, and Basic

Requirement 18, Audits, and the following supplemental requirements of ANSI/ASME

NQA-1-1994:

• 18S-1, Supplementary Requirements for Audits

In addition, Personnel who perform audits are qualified to the requirements of NQA-1-

1994, Supplement 2S-3, and ANSI N45.2.23.

18.1 Purpose

This section describes the elements of quality auditing.

18.2 General

The AREVA NP Inc. audits program is defined by written procedures providing program

definition as well as direction and guidance for audits and the supporting activities

concerned. These procedures establish the scheduling, preparation, execution,

reporting, and follow-up methods to be used in implementing the audits program. The

audits conducted under the QA audits program include:

• An objective evaluation of quality related practices, procedures, and instructions

• The effectiveness of implementation

• Conformance with policies and procedures

• Indoctrination and training programs

• Interfaces within AREVA NP Inc. and with the customer

• Corrective action, calibration, and nonconformance control systems

• Design Control, calculations and associated computer codes

• Review of documents and records

Audits are regularly scheduled based upon the status and safety related importance of

the activities being performed and are initiated early enough to assure effective QA

during design, procurement, fabrication, inspection, and testing. Audits are performed


in accordance with pre-established written procedures or checklists and conducted by

personnel having no direct responsibilities in the areas being audited. Personnel who

perform audits are qualified to the requirements of ASME NQA-1-1994, Supplement 2S-

3, and ANSI N45.2.23. Certification files are maintained in the AREVA NP Inc. QA

Department and Records Management.

Audit plans are developed and documented for each audit. The Audit Plan identifies the

scope of the audit, applicable requirements and audit personnel, activities to be audited,

organizations to be notified, applicable documents, schedule, and written procedures

and checklists.

Responsibilities within the audit program are not delegated; AREVA NP Inc. maintains

responsibility for the audit program effectiveness.

18.3 Internal Audits

Internal audits of AREVA NP Inc. activities are used to evaluate compliance with, and

the effectiveness of, the QAP. These audits are scheduled to cover the quality program

elements once each calendar.

Audit results of AREVA NP Inc. activities are provided to the managers of the

organizations audited, the President and CEO of AREVA NP Inc., and the Vice

President, Quality & Performance for review, analysis, and direction. Managers of the

audited organizations investigate audit findings, determine cause, schedule corrective

action, including measures to prevent recurrence, and provide written responses to the

findings of the audit. Follow-up is conducted by QA to ensure implementation of

appropriate corrective and preventive actions. When necessary, follow-up will include

an audit of deficient areas.

18.4 Supplier Audits

Suppliers of safety-related items and services are evaluated to assure that only qualified

suppliers are used. An audit is performed when sufficient work is in progress to


demonstrate that the supplier is implementing a QA program. Qualified suppliers are

audited on a triennial basis. In addition, if a subsequent contract or a contract

modification significantly enlarges the scope of or changes the methods or controls for

activities performed by the same supplier, an audit of the modified requirements is

conducted, thus starting a new triennial period. AREVA NP Inc. may utilize audits

conducted by outside organizations for supplier qualification provided that the scope

and adequacy of the audits meet AREVA NP Inc. requirements. Documented annual

evaluations are performed for qualified suppliers to assure they continue to provide

acceptable products and services. Industry programs, such as those applied by ASME,

Nuclear Industry Assessment Committee (NIAC), or other established utility groups, are

used as input or the basis for supplier qualification whenever appropriate. The results

of the reviews are promptly considered for effect on a supplier’s continued qualification

and adjustments made as necessary (including corrective actions, adjustments of

supplier audit plans, and input to third party auditing entities, as warranted). In addition,

results are reviewed periodically to determine if, as a whole, they constitute a significant

condition adverse to quality requiring additional action.

Evaluations of suppliers are documented and take into account the following, where

applicable:

• Receipt inspection, operating experience, and supplier evaluation programs are reviewed on an ongoing basis as the information becomes available. The results of the review are promptly considered for effect on a suppliers continued qualification and adjustments made as necessary (including corrective actions, adjustments of suppliers audit plans and input to third party auditing entities as warranted). Additionally, results are reviewed periodically to determine if, as a whole, they constitute a significant condition adverse to quality requiring additional action.

• If there is no ongoing receipt inspection or operating experience with which to analyze the supplier for a period of twelve (12) months, an annual evaluation shall be performed as follows: - Review of supplier-furnished documents and records such as certificates of

conformance, nonconformance notices, and corrective actions - Results of previous source verifications, audits and receiving inspections


- Operating experience of identical or similar products furnished by the same supplier

- Results of audits from other sources (e.g., customers, ASME, NIAC (Nuclear Industries Assessment Committee) or NRC audits)

18.5 Audit Reports

The audit report is signed by the audit team leader and issued. The report includes the

following information as appropriate:

• Description of audit scope

• Identification of auditors

• Identification of persons contacted during the audit activity

• Summary of audit results including a statement on the effectiveness of the QA program elements which were audited

• Description of each reported adverse audit finding in sufficient detail to enable corrective action to be taken by the audited organization


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page A-1

APPENDIX A

QA Program Implementing Policies, Procedures, and Instructions

Document Number Document Title

Applicable QA Document Section

Policy 0401 Evaluation and Reporting Per 10 CFR 21 4, 7, 15 Policy 0402 Quality Assurance Program 1,2 Policy 0501 Approval, Control, and Management of

Corporate Policies and Implementing, Procedures

5, 6

0303-09 Project Work Authorization 2, 3 0310-03 Authorization of Contract Work 2, 3 0310-05 Product Numbering 8 0310-38 Historical Documents List (HDL) 6, 17 0313-01 Nuclear parts Center Contract Administration 4, 6, 7 0402-01 Calculations 3, 6 0402-02 Peer Reviews 3, 6 0403-11 Technical Document Signatures 3, 6 0405-03 Plant Technical Requirements Document 3, 6 0405-05 Contract Variation Approval Requests 15, 16 0405-11 General Design Text Documents 3, 6 0405-12 General Design Drawings 3, 5, 6 0405-13 Project Design Guideline and Directives 2, 3 0405-14 Developing and Implementing a Reliability

Assurance Program for U.S. EPR Projects 2, 3

0405-22 Design Review Boards 3 0405-30 Design Verification Testing 3-6, 11 0405-37 Maintenance of ASME Code Certification

Requirements for Professional Engineers 3

0411-08 Revising and Processing Product Documentation Prepared by Suppliers

3, 6

0412-55 Developing and Revising Specifications 3-6, 11, 13 0412-59 Engineering Technical Documents 3, 5, 6, 11 0412-63 Technical Document Format 3, 5, 6





0412-66 Release of Product Documentation 3-6 0412-67 Processing Technical Documents from

Suppliers and Customers 3-7

0412-76 Dedication (10 CFR Part 21) 4, 7, 15 0413-05 Acting as an Owners Agent for Review of

Design (Stress) Reports and Addendum (ASME Code Components)

3, 6

0414-12 Preparation and Processing of Licensing Documents

3, 6

0418-01 Preparation, Control, and Revisions to Final Safety Analysis Report - FSAR

3, 6

0418-02 Managing Interface with the Nuclear Regulatory Commission

3

0504-15 Preparing and Processing Operating Guidelines 3, 6 0504-16 Nuclear Products Advisory Bulletins (NPAB) 16 0509-11 Measuring and Test Equipment Calibration 12 0902-12 Certification File Access Control System for

Computers Using a UNIX-Based Operating System

3

0902-13 Production System Software and Hardware changes

3

0902-19 Engineering Software Error Reporting and Evaluation

3

0902-28 Development of Engineering Applications Software

3

0902-29 Procurement of Engineering Applications Software

3, 4, 7

0902-30 Management and Use of Engineering Applications Software

3, 6

0903-03 Development and Control of Software Documentation

3, 6

1212-12 Purchasing Documents 4 1303-07 Control of Corporate Policies and Implementing

Documents 5, 6

1303-17 Operating Instructions 5, 6 1702-22 Employee Training 2





1702-25 Assignment of Nuclear Safety Classification to Products and Services

2

1703-01 Restraint Order 15, 16 1705-03 Quality Assurance Data Packages and

Certificates of Conformance 7

1705-16 QA Review of Procurement Packages (Purchasing Requisition) and Customer Order Entry Document (COED) Packages

4

1707-01 Evaluation and Reporting per 10 CFR 21 15, 16 1708-08 Quality Control Surveillance 7 1710-01 Appointment of Level III NDE Examiner 9 1710-02 Appointment of Level III Quality Control

Inspection and Surveillance (QCI&S) Examiner 7, 10

1710-03 Process management 5 1717-06 Corrective Action Program (WebCAP) 15, 16 1719-21 Quality Assurance Audits of Internal Activities 18 1719-22 Quality Assurance Audits of Suppliers 7, 18 1719-23 Qualification of Quality Assurance Audit

Personnel 2, 18

1719-32 Self-Assessment 15, 16 1720-01 Review and Dissemination of Regulatory

Actions and Industry Events 3

1720-02 10 CFR 50.46 Reporting Requirements 3 1721-01 Quality Engineering (QE) Surveillance of

Engineering Activities 2, 3

1724-01 Supplier Quality Oversight 4, 7 1729-01 Quality, Safety and Environmental Management

System Management Reviews 15, 16

1902-12 Proprietary Classification of Technical Documents and Sensitive Information

3

1902-14 Control of Safeguards Information 3 56-9141754 AREVA Inc. Quality Assurance Program All 56-1151178 AREVA NP Inc. ASME Section III and XI

Quality Assurance Manual All

1E1 Records Management Program Manual 17 105-5017274 Projects Manual 2, 3





EG-01 Plants U.S. Training Program 1, 2 EG-02 Customer Feedback Survey Process 16 EG-03 Customer Feedback Evaluation Process 16 EG-04 External Communications 2 EG-05 Tracking Customer Deliverables 2 EG-06 Engineering Task Plans 2 EG-07 Engineering Qualification Process 2 EPR-EN-PR-1002 Design Control Process 3, 5 EPR-EN-PR-1003 Design Change Control Process 3, 5 EPR-EN-PR-1004 Development of System Design Requirements

Documents 3, 5

EPR-EN-PR-1005 Establishing Structures, Systems and Components Safety Classifications

3, 5

EPR-EN-PR-1006 Development of System Description Documents 3, 5 EPR-EN-PR-1007 Design Interface Control 3, 5 EPR-EN-PR-1009 Development of Analytical Input Requirements

Specifications (AIRS) 3, 5

EPR-EN-PR-1011 Structure, System and Component Design Bases

3, 5

EPR-EN-PR-1012 Development of I&C Requirements 3, 5 EPR-EN-PR-1013 Interdisciplinary Coordination and Review

Process 3, 5

EPR-EN-PR-1016 Requirements for the Electrical Load Lists 3, 5


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page B-1

APPENDIX B

Regulatory Commitments: Compliance with Applicable Regulatory Guides,

Generic Letters, and Standards

I. AREVA NP Inc.’s position with respect to the NRC Regulatory Guides pertaining to Quality Assurance as they apply to the AREVA NP Inc. scope of supply is as follows: a. Regulatory Guide 1.26, Quality Guide Classifications and Standards for

Water, Steam, and Radioactive Waste Containing Components of Nuclear Power Plants, Revision 4 – AREVA NP Inc. complies with the provisions of this Guide. AREVA NP Inc. generally classifies nuclear core components as safety related.

b. Regulatory Guide 1.28, Quality Assurance Program Requirements (Design & Construction, Revision 2 – this Guide endorses ANSI N45.2-1977, “Quality Assurance Program Requirements for Nuclear Power Plants,” as an appropriate basis for compliance with Appendix B of 10 CFR 50, Appendix B. AREVA NP Inc. complies with the provisions of this Guide.

c. Regulatory Guide 1.28, Quality Assurance Program Requirements (Design & Construction), Revision 3 – this Guide endorses ANSI/ASME NQA-1 as an appropriate basis for compliance with 10 CFR 50, Appendix B. AREVA NP Inc. complies with the provisions of this Guide with the following clarifications:

i. Regulatory Guide 1.28, Section C.1: Qualification of Inspection and Test Personnel – AREVA NP Inc. follows the regulatory position provided in Regulatory Guide 1.28, Section C.1 with the clarifications supplied for Regulatory Guide 1.58 in this Appendix.

ii. Regulatory Guide 1.28, Section C. 2: Quality Assurance Records – AREVA NP Inc. follows the regulatory position provided in Regulatory Guide 1.28, Section C.2 with the clarification supplied for Regulatory Guide 1.88 in this Appendix.

iii. Regulatory Guide 1.28, Section C.3: Audits – AREVA NP Inc. follows the regulatory position provided in Regulatory Guide 1.28, Section C.3 with the clarifications supplied in Regulatory Guide 1.144 in this Appendix.

iv. ANSI/ASME NQA-1, Section 4.0, Design Verification – the clarifications noted for Regulatory Guide 1.64 in this Appendix, regarding the use of managers or supervisors as independent reviewers, applies.



d. Regulatory Guide 1.29, Seismic Design Classification, Revision 4 – AREVA NP Inc. complies with the provisions of this Guide.

e. Regulatory Guide 1.30, Quality Assurance Requirements for Installation, Inspection, and Testing of Instrumentation and Electrical Equipment, Revision 0 – this Guide endorses ANSI N.45.2.4 – 1972 (IEEE Standard 336 – 1971), “Installation, Inspection, and Testing Requirements of Instrumentation and Electrical Equipment During the Construction of Nuclear Power Generating Stations,” as an adequate basis for compliance with 10 CFR 50, Appendix B. This standard applies to on-site installation, inspection, and testing of safety related instrumentation and electrical equipment. This function is normally the responsibility of the plant owner, and this standard is reflected in the owner’s procedures applicable to the work. AREVA NP Inc. provides appropriate drawings, instructions, and consultation to aid the owner in compliance with this Guide.

f. Regulatory Guide 1.37, Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components of Water-Cooled Nuclear Power Plants, Revision 1. AREVA NP Inc. complies with the provisions of this Guide.

g. Regulatory Guide 1.58*, Qualification of Nuclear Power Plant Inspection, Examination, and Testing Personnel, Revision 1 – this Guide endorses ANSI N45.2.6 – 1978, “Qualifications of Inspection, Examination, and Testing Personnel for the Construction Phase of Nuclear Power Plants,” for use in compliance with 10 CFR 50, Appendix B. Although ANSI N.45.2.6 – 1978 is applicable only to the construction phase of a nuclear power plant, this Regulatory Guide states that the provisions of ANSI N45.2.6 – 1978 are “generally applicable… during fabrication prior to receipt of items at the construction site.” AREVA NP Inc. satisfies this Guide through ensuring that off-site inspection, examination, or testing is performed and/or monitored by AREVA NP Inc. QA representatives qualified to meet the applicable requirements of ANSI N45.2.6. AREVA NP Inc. ensures that nondestructive examinations are performed by personnel certified to SNT-TC-1A in compliance with Section 2 of this Guide, and those other inspections, examinations, or testing is performed by personnel qualified in accordance with applicable requirements.

h. Regulatory Guide 1.64*, Quality Assurance Requirements for the Design of Nuclear Power Plants, Revision 2 – this Guide endorses ANSI N45.2.11 – 1974, “Quality Assurance Requirements for the Design of Nuclear Power Plants,” as acceptable for compliance with 10 CFR 50, Appendix B with noted amplifications.



The following AREVA NP Inc. clarification is identified with respect to Section C.2 of this Guide regarding the use of managers or supervisors as independent reviewers: All design documents are independently reviewed for completeness and technical accuracy. The reviewer may be: (1) Any competent individual other than the preparer of the document as

determined by the cognizant manager. (2) The preparer’s immediate supervisor provided the supervisor did not

prescribe or limit the techniques or inputs used in the design document. The use of supervisors as reviewers is approved in each instance by the cognizant manager.

(3) The preparer’s manager provided the manager is the only technically qualified individual available. In this case, the need is documented and approved by the next higher level of management on each occasion.

i. Regulatory Guide 1.74*, Quality Assurance Terms and Definitions, Revision 0 – this Guide endorses ANSI N45.2.10 – 1973, “Quality Assurance Terms and Definitions,” for use in describing and implementing quality assurance programs. AREVA NP Inc. uses the appropriate definitions of ANSI N45.2.10 – 1973 and supplements these terms with others considered necessary to provide a common interpretation of the AREVA NP Inc. QAP. These provisions satisfy this Regulatory Guide.

j. Regulatory Guide 1.88*, Collection, Storage, and Maintenance of Nuclear Power Plant Quality Assurance Records, Revision 2 – this Guide endorses ANSI N45.2.9 – 1974, “Requirements for Collection, Storage, and Maintenance of Quality Assurance Records for Nuclear Power Plants,” for use in compliance with criterion XVII of 10 CFR 50, Appendix B. The AREVA NP Inc. Records Management Manual complies with this Regulatory Guide, effective June 16, 1975.

k. Regulatory Guide 1.123*, Quality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants, Revision 1 - this Guide endorses ANSI N45.2.13 – 1976, “Quality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants.” AREVA NP Inc. complies with the provisions of this Guide.

l. Regulatory Guide 1.144*, Auditing of Quality Assurance Programs for Nuclear Power Plants, Revision 1 – this Guide endorses ANSI N45.2.12-1977, “Requirements for Auditing of Quality Assurance Programs for Nuclear Power Plants.” The standard establishes requirements for conducting audits of quality assurance programs both internally and externally (suppliers). AREVA NP Inc. satisfies the requirement for internal audits by auditing each applicable element of its Quality Assurance Program at least once during a calendar year. External (Supplier) audits are regularly scheduled on the basis of supplier performance and importance to safety of the activities being



performed. Audit frequency of suppliers, normally between one and three years, may be altered (increased or decreased) based on an annual evaluation of the supplier’s quality assurance program, history of performance, and implementation of that program. This evaluation considers the complexity of the system or component concerned and the degree of quality and process control required by the manufacturing effort.

m. Regulatory Guide 1.146*, Qualification of Quality Assurance Program Audit Personnel for Nuclear Power Plants, Revision 0 – this Guide endorses ANSI N45.2.23 – 1978, “Qualification of Quality Assurance Program Audit Personnel for Nuclear Power Plants.” AREVA NP Inc. complies with the provisions of this Guide.

n. Generic Letter 89-02, “Actions to improve the dedication of counterfeit and fraudulent marketed products.” AREVA NP Inc. conforms to the provisions of this generic letter.

o. Generic Letter 91-05, “Licensee Commercial Grade Dedication Programs.” AREVA NP Inc. conforms to the provisions of this generic letter.

p. ANSI/ASME NQA-1-1994 Edition, Subpart 2.7, “Quality Assurance Requirements of Computer Software for Nuclear Facility Application.” AREVA NP Inc. conforms to the provisions of this subpart.

q. Regulatory Issues Summary 2000-18, “Guidance on Managing Quality Assurance Records in Electronic Media.” AREVA NP Inc. conforms to the provisions of this guidance.

r. Nuclear Information and Management Association Inc. (NIRMA) Technical Guide (TG) 11-1998, “Authentication of Records and Media.” AREVA NP Inc. conforms to the provisions of this guide.

s. NIRMA TG-15-1998, “Management of Electronic Records.” AREVA NP Inc. conforms to the provisions of this guide.

t. NIRMA TG-16-1998, “Software Configuration Management and Quality Assurance.” AREVA NP Inc. conforms to the provisions of this guide.

u. NIRMA TG-21-1998, “Electronic Records Protection and Restoration.” AREVA NP Inc. conforms to the provisions of this guide.

II. AREVA NP Inc.’s review and analysis of the following QA related regulatory guides indicate that they are applicable to the AREVA NP Inc. scope of supply if invoked by a customer. a. Regulatory Guide 1.39, Housekeeping Requirements for Water-Cooled

Nuclear Power Plants, Revision 0 – this guide endorses ANSI N45.2.3-1973, “Housekeeping During Construction Phase of Nuclear Power Plants.”

III. AREVA NP Inc.’s review and analysis of the following QA related regulatory guides indicate that they are not applicable to the AREVA NP Inc. scope of supply.



a. Regulatory Guide 1.94, Quality Assurance Requirements for Installation, Inspection, and Testing of Structural Steel During the Construction Phase of Nuclear Power Plants, Revision 1

NOTE: The asterisk (*) indicates regulatory guides which were withdrawn by the NRC. They are included in this Document because selected utilities were licensed to these requirements.


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report Page C-1

APPENDIX C

Definitions

Acceptance Criteria

Specified limits placed on characteristics of an item, process, or service defined in

codes, standards, or other requirements documents and used to determine whether an

item, process, or service is satisfactory.

Annual

Defined as occurring within a calendar year, performance of duties shall not be less

than 10 months or more than 14 months. Individual procedures may be more

restrictive.

Approval

The act of endorsing or assigning positive authorization, or both.

As-Built Data

Documented data that describes the condition actually in an item.

Audit

A planned and documented activity performed to determine by investigation,

examination, or evaluation of objective evidence the adequacy of and compliance with

established procedures, instructions, drawings, and other applicable documents, and

the effectiveness of implementation. An audit should not be confused with surveillance

or inspection activities performed for the sole purpose of process control or product

acceptance.



Certificate of Conformance (CoC)

A document signed or otherwise authenticated by an authorized individual certifying the

degree to which items or services comply with specified requirements.

Characteristic

Any property or attribute of an item, process, or service that is distinct, describable, and

measurable.

Cleanliness

A state of being clean in accordance with predetermined standards, and usually implies

freedom from dirt, dust, rust, oil, or other contaminating impurities.

Critical Characteristic

Those characteristics that are essential for performance of an item’s safety related

function(s). Typical critical characteristics are attributes such as form, fit, dimensions,

material including physical, mechanical, and chemical properties, electrical, thermal, or

other functional parameters.

Commercial Grade Item

When applied to nuclear power plants licensed pursuant to 10 CFR 50, commercial

grade item means a structure, system or component, or part thereof that affects its

safety function, that was not designed and manufactured as a basic component.

Commercial grade items do not include items where the design and manufacturing

process require in-process inspections and verifications to ensure that defects or

failures to comply are identified and corrected, i.e., one or more critical characteristics of

the item cannot be verified.



Computer Program (Code Software)

A sequence of instructions suitable for processing by a computer. Processing may

include the use of an assembler, a compiler, and interpreter, or a translator to prepare

the program for execution as well as to execute it.

Condition Adverse to Quality

An all inclusive term used in reference to any of the following: failures, malfunctions,

deficiencies, defective items, and nonconformances. A significant condition adverse to

quality is one which, if uncorrected, could have a serious effect on safety and

operability.

Corrective Action

Measures taken to rectify conditions adverse to quality and, where necessary, to

preclude repetition.

Defective Material and Equipment

A material or component which has one or more characteristics that do not comply with

specified requirements.

Deficiency

The quality or condition of being deficient; incompleteness or inadequacy.

Deviation

A nonconformance or departure of a characteristic from specified requirements.

Document

Any written or pictorial information describing, defining, specifying, reporting, or

certifying activities, requirements, procedures, or results.



Document Master Lists

Lists of documents to which an individual may refer to determine the current revisions of

documents applicable to an activity, project, or contract. Includes such lists as:

applicable documents list, contract documents list, historical documents list, procedure

document table of contents or plan list, etc.

Documentation

A compilation of those documents concerning a specific function, activity or project.

Examination

An element of inspection consisting of investigation of materials, components, supplies,

or services to determine conformance to those specified requirements which can be

determined by such investigations. Examination is usually nondestructive and includes

visual, simple physical manipulation, gauging, measurement and written documentation.

Failures

A failing (or number of failings) to perform a duty or expected action.

Handling

An act of physically moving and/or lifting items by hand or mechanical means.

Hold

An action by a quality organization wherein an item is withheld and segregated from

further processing until a disposition has been defined and imposed.

Hold Point

A point at which witnessing of examinations is required by the quality organization or

customer and beyond which point work shall not proceed without consent of the quality

organization or customer representative respectively.



Inspection

Examination or measurement to verify whether an item or activity conforms to specified

requirements.

Inspection and Test Records

Documents that furnish evidence of the completion of inspection and tests. They

contain the following, where applicable: a description of type of observation, the date

and results of the inspection or tests, inspector or data recorder identification, evidence

of acceptability of the item inspected or tested, and action taken to resolve any

nonconformances noted.

Inspector

A qualified individual whose duties include verification of quality related activities and

who is independent of the activity being verified.

Item

An all-inclusive term used in place of any of the following: appurtenance, assembly,

component, equipment, material, module, part, structure, sub-assembly, sub-system,

system, or unit.

Malfunctions

To function imperfectly or badly, fails to operate in the normal or usual manner.

Measuring & Test Equipment

Devices or systems used to calibrate, measure, gauge, test, or inspect in order to

control or to acquire data to verify conformance to specified requirements.



Nonconformance

A deficiency in characteristic, documentation, performance, or procedure which renders

the quality of an item unacceptable or indeterminate.

Non-Destructive Examination

A method of detecting indications of discrepancies without destroying the usefulness of

the item or material.

Non-Safety Related

Any item or service that has quality requirements greater than commercial, but less than

safety related as defined by specific customer procurements.

Objective Evidence

Any statement of fact, information, or record, either quantitative or qualitative pertaining

to the quality of an item or service which can be verified by records of tests,

examinations, inspections, measurements, or observations.

Out of Commission

An item of equipment that is not able to perform its intended function.

Procedure

A document which specifies instructions for performance of a particular task. It includes

methods to be employed, description of equipment or material to be used, sequence of

operations, etc.

Process

One or more operations, methods, functions, procedures, or other specified actions

which result in the desired item or result.



Purchasing Authorization

A document used to transmit procurement information/documents to purchasing for the

purpose of obtaining bids, placing orders and change orders.

Purchasing Document

A contractually binding document identifying and defining the requirements which items

or services must meet prior to acceptance. Also includes purchasing authorizations,

purchase requisitions, purchase orders, contracts, drawings, specifications, or

instructions.

Purchase Requisition

Electronic generated requests used to transmit procurement information/documents to

purchasing for the purpose of obtaining bids, placing orders and change orders.

Project Management Function

An individual responsible for technical contract, quality, budget, schedule or delivery of

a product or service.

Qualification (Personnel)

The characteristics or abilities of an individual, gained through training and/or

experience that enables him to perform specific functions.

Qualified Equipment

Equipment which has been evaluated by sufficient testing to assure performance within

specified parameters.

Qualified Party or Individual

A person or organization competent and recognized as knowledgeable to perform

certain functions.



Qualified Procedure

A procedure which incorporates all applicable code and standard requirements,

manufacturing parameters, and specifications, which has been proven adequate for the

intended purpose.

Quality

The properties or characteristics constituting those prerequisites or specifications,

codes, standards, industrial practices, other recognized methods and/or acceptance

criteria by which an item is judged.

Quality Assurance

All those planned and systematic actions, including quality administration and quality

control, which provide adequate confidence that an item will perform satisfactorily in

service.

Quality Assurance Plan

The application of a contract which implies a departure from the general requirements of

the QA Program may be addressed in a Quality Assurance Plan. It may also reflect

additions that a customer invokes in a contract.

Quality Assurance Record

A completed document that furnishes evidence of the quality of items and/or activities

affecting quality. Records must be validated by stamps, initials, or signatures of

authorized personnel or otherwise authenticated.

Quality Control

Those quality assurance actions which provide a means to control and measure the

characteristics of an item or process to established requirements.



Reject

A disposition which may be imposed on a nonconforming item providing for its

withdrawal and isolation from further processing pending an evaluation as to repair,

rework, use-as-is, or scrap.

Repair

The process of restoring a nonconforming characteristic to a condition such that the

capability of an item to function reliably and safely is unimpaired, even though the item

still may not conform to the original requirements in every aspect.

Review/Approval

Acceptance indicated by signature/initials and date.

Rework

The process by which a nonconforming characteristic to a condition such that he

capability of an item to function reliably and safely is unimpaired, even though the item

still may not conform to the original requirements in every aspect.

Safety Related

Safety related items are the equipment that is relied upon to remain functional during

and following design basis events to ensure:

• The integrity of the reactor coolant pressure boundary.

• The capability to shut down the reactor and maintain it in a safe shutdown; or

• The capability to prevent or mitigate the consequences of accidents that could result in potential offsite exposure comparable to the guidelines in 10 CFR 50.34(a)(1), 50.67(b)(2), or 100.11 of this chapter, as applicable.

Scrap

A disposition which may be imposed upon a nonconforming item when it has been

established that the discrepancy renders the item unfit for its intended use and it is not



economically or otherwise feasible to repair or rework it. Scrap may also be excess

material or damaged material remaining from fabrication operations which is unsuitable

for further use.

Service

The performance of activities such as engineering, inspection, test, nondestructive

examination, destructive examination, qualification of personnel, procedures and

equipment, audits, and calibration of measuring and test equipment.

Source Inspection or Surveillance

A review, observation or inspection for the purpose of verifying that an action has been

accomplished as specified at the location of item procurement or manufacture.

Special Process

A process, the results of which are highly dependent on the control of the process or the

skill of the operators, or both, and in which the specified quality cannot be readily

determined by inspection or test of the product.

Specification

A concise statement of a set of requirements to be satisfied by a product, material, or

process indicating, whenever appropriate, the means by which it may be determined

whether the requirements given are satisfied.

Substantial Safety Hazard

A loss of safety function to the extent that there is a major reduction in the degree of

protection provided to public health and safety for any licensed facility.



Supplier

Any individual or organization who furnishes items or services in accordance with a

procurement document. An all inclusive term used in place of any of the following:

vendor, seller, contractor, sub-contractor, fabricator, consultant, and their sub-tier levels.

Surveillance

The act of monitoring or observing to verify whether an item or activity conforms to


Testing

An element of verification for the determination of the capability of an item to meet

specified requirements by subjecting the item to physical, chemical, environmental, or

operating conditions.

Traceability

The ability to trace the history, application, or location of an item and like items or

activities by means of recorded identification.

Use-As-Is

A disposition permitted for a nonconforming item when it can be established that the

item is satisfactory for its intended use.

Verification

The act of reviewing, inspecting, testing, checking, auditing, or otherwise determining

and documenting whether items, processes, services, or documents conform to


Waiver

Documented authorization to depart from some specified requirements.



Witness

To observe a performance.

Witness Point

A step in a process for which the quality organization or customer has requested

notification. An organization may proceed past a witness point if the quality

organization or customer representative is not present at the appointed time.


AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™ Topical Report AP-1

ADDENDUM A

Non-Safety Related Products and Services

A-0 INTRODUCTION

This Document Addendum describes the Quality Assurance Plan (QAP) for the non-

safety related products and services supplied by AREVA NP Inc. This excludes safety

related products and services as listed in Section 1 – 18 of this document and ASME

Boiler & Pressure Vessel Code items and activities which are covered by separate QAP

documents.

A-1 ORGANIZATION

Same as Document Section 1.

A-2 QUALITY ASSURANCE PROGRAM

A-2.1 Scope

This QAP for non-safety related products and services takes into account the

prerequisites for achieving quality, such as the need for specialized equipment and

skills, use of administrative, process, and environmental controls, training and

indoctrination of personnel performing activities affecting quality, and the need for

verification of quality by inspection and test.

The classification of items and services as non-safety related is made and documented

by the responsible technical manager and project management functions. The criteria

for determining this classification is contained in an implementing procedure.

Essentially, any item or service that has quality requirements greater than commercial,

but less than safety related as defined by specific customer procurements both internal

and external is considered to be non-safety related (refer to Appendix C for definitions).



A-2.2 QAP Requirements

This QAP for non-safety related products and services is organized and administered to

comply with the Quality Policy in the front of this document. It also allows for quality

requirements as may be imposed by contract. This QAP establishes minimum

requirements for non-safety related products and services.

At the discretion of the project management function, their products and services may

be processed as safety related per Sections 1 – 18 of this document.

A-2.3 QAP Implementation

The policies, procedures, and instructions identified in Appendix A apply to this

Addendum.

A-2.4 QAP Assessment

This Addendum is updated as determined by the Vice President, Quality &

Performance.

A-2.5 QAP Indoctrination and Training

Same as document Section 2.1.6 except documentation of qualifications for personnel

performing inspection, surveillance, and audit activities are not required.

A-3 DESIGN CONTROL

A-3.1 Scope

Design control measures are applied to non-safety related items and services as

defined in written procedures and instructions.

AREVA NP Inc. maintains design control only during the performance of contracted

work. Control of design configuration prior to and after completion of a contract is the

responsibility of the customer.



A-3.2 Design Documents

The cognizant technical manager is responsible for the preparation, review, and

approval of design documents for items and services within their respective areas of

expertise. Design documents include such documents as specifications, requirements

documents, drawings, and analyses. These documents specify technical and quality

requirements appropriate to the activities they cover.

Design documents are reviewed for completeness and technical accuracy. The

reviewer may be any technically qualified individual other than the preparer of the

document.

Spare or replacement items may be designed and procured to the original or equivalent

requirements. The requirements may be defined by the original specifications and/or by

AREVA NP Inc., the OEM, or the customer. Product specifications and drawings are

prepared, reviewed, and approved as stipulated in written procedures.

A-3.3 Design Interfaces

The preparers/reviewers of design documents are responsible to assure the

consideration of design interfaces. The project management function coordinates

design interfaces with the customer. The customer may assume responsibility for

specifying, reviewing for accuracy, and approving physical and functional interface, with

existing customer equipment and systems which affect the performance of AREVA NP

Inc. work. Alternatively, the customer may choose to contractually delegate this

responsibility to AREVA NP Inc. and, accordingly, furnish AREVA NP Inc. with adequate

records and documentation from which such interfaces can be defined.

A-3.4 Design Verification

The responsible technical manager and project management functions determine the

need for design verification. Verification methods include design analyses

(calculations), design review boards, and design verification testing.



A-3.4.1 Design Analyses

Design analyses (calculations) may be used to establish design requirements or to

verify a design. Calculations are documented and reviewed for technical accuracy. The

reviewer may be any technically qualified individual other than the preparer of the

calculation. Computer programs used for design analyses are verified to the extent

necessary to assure that they perform their intended functions.

A-3.4.2 Design Review Boards

Same as Document Section 3.6.3.

A-3.4.3 Testing

Testing is used to demonstrate that designs or design features are suitable for their

intended applications. The criteria for such testing is determined and documented in

written test procedures by the responsible technical manager. Test results are reviewed

by the responsible technical manager against this criterion.

A-3.5 Design Changes

Design changes are subject to the same design controls that were applicable to the

original design.

A-3.6 Engineering Assistance/Advice and Consultation

Same as Document Section 3.8.

A-4 PROCUREMENT DOCUMENT CONTROL

A-4.1 General

Controls are established by written procedures to assure that procurement documents

contain appropriate quality, technical, and manufacturing requirements.



A-4.2 Procurement Process

Purchasing Authorizations (PA) are used to identify the technical, quality, and other

requirements applicable to commercial items and/or services to be procured with limited

quality scope. PA’s are prepared, reviewed, and approved as prescribed in procedures.

Other commercial items/services may be purchased using purchase requisitions or

electronic requisitioning.

The project management function is authorized to procure items and/or services directly

from other AREVA NP Inc. organizations using the PA as the contract with these

organizations.

Orders placed with all other suppliers, including other AREVA NP organizations, are

processed through Purchasing. Purchasing converts the PA/PR into a Purchase Order

(PO) or Change Order (CO). The PO/CO is then sent to the supplier.

A-4.3 Procurement Document Review

Procurement documents, at the discretion of the project management function, may be

reviewed by QA to determine that requirements are correctly stated and that the

procurement is properly classified as non-safety related.

A-4.4 Changes to procurement Documents

Changes to procurement documents are processed in the same manner as the original

procurement documents.

A-5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS

A-5.1 General

All activities affecting quality are prescribed by instructions, procedures, or drawings

appropriate to the circumstances and accomplished accordingly. Instructions,

procedures, and drawings include or reference adequate quantitative or qualitative

criteria for determining that important activities have been satisfactorily accomplished.



A-5.2 Administrative Policies, Procedures, and Instructions

This QAP is implemented through this Document Addendum, and written administrative

policies, procedures, and instructions. These policies, procedures, and instructions are

prepared by responsible personnel, reviewed by other organizations to whom they

apply, and then reviewed and approved by QA before they are approved and distributed

for use.

A-5.3 Drawings and Specifications

Drawings, specifications, and other documents are released for use in engineering,

procurement, manufacturing, and field activities as described in Section A-6.

A-5.4 Manufacturing, Inspection, and Test Plans

The responsible technical manager prescribes the applicable drawings, specifications,

and procedures to be used in the manufacture, inspection, and test of non-safety

related items.

A-6 DOCUMENT CONTROL

A-6.1 General

Design documents (calculations, drawings, specifications), procurement documents,

and instructions are prepared, reviewed, approved, and issued in accordance with

procedures or instructions.

Established procedures assure technical adequacy of, and inclusion of, appropriate

requirements in the above documents by requiring reviews by qualified reviewers prior

to their implementation. Changes to these documents are processed in the same

manner as the original documents.



A-6.2 Document Control System

Technical documents including design documents (drawings, instructions, test

procedures, customer supplied technical documents, etc.) relating to activities affecting

quality are maintained, controlled, and issued in a manner to assure the correct and

applicable documents are used at the location where the activity is performed.

Documents are maintained, stored, and released by Records Management.

A-7 CONTROL OF PURCHASED ITEMS AND SERVICES

Same as Document Section 7 with the following exceptions:

• The requirements of document Sections 7.1 – 7.5, and 7.8 do not apply unless specifically requested by the organization requesting the product or service. It is the responsibility of the requisitioning organization and/or purchasing to assure that non-safety related items and services are procured from reputable suppliers with known capability of providing the items or services being purchased.

• Incoming items received at AREVA NP Inc. for use in non-safety related applications, at a minimum, undergo a visual inspection for shipping damage and verification that the items received were the items ordered. Additional requirements may be imposed by the responsible technical manager or by contract.

• Certificates of Conformance/QA Data Packages are not furnished for non-safety related items or services unless requested by the customer’s purchase order.

However, if required by contract, Certificates of Conformance (CoC) are prepared by

the responsible Unit Manager or designee for items provided by AREVA NP Inc. to

customers for their use. These CoC’s are signed by the responsible Unit Manager or

designee prior to shipment of the items.

A-8 IDENTIFICATION AND CONTROL OF ITEMS

The controls specified in document Section 8 can be applied when these controls are

identified by the responsible technical manager in appropriate drawings and design

documents.



A-9 CONTROL OF PROCESSES

The controls specified in Document Section 9 are invoked by the responsible technical

manager in accordance with the contract.

A-10 INSPECTION

Inspections of non-safety related items for acceptability are performed and documented

as specified by the responsible technical manager. Inspections may be performed by

any competent individual using measuring and test equipment (M&TE) calibrated and

controlled in accordance with Section A-12. Any nonconformances found during

inspections are processed as described in Section A-15.

A-11 TEST CONTROL

Tests of non-safety related items are performed and documented as specified in written

procedures by the responsible engineering function. M&TE used during the

performance of tests is calibrated and controlled as specified in Section A-12.

A-12 CONTROL OF MEASURING AND TEST EQUIPMENT

Same as document Section 12. However, the following exceptions may be utilized

provided M&TE for non-safety related items is segregated from M&TE for safety related

systems.

• M&TE may be calibrated against reference standards having an accuracy at least that of the M&TE being calibrated.

• Suppliers of calibration services for M&TE need not be QA audited and approved suppliers.

A-13 HANDLING, STORAGE, AND SHIPPING

Same as document Section 13 except tagging of stored items is not required.



A-14 INSPECTION, TEST, AND OPERATING STATUS

Inspection, test, and operating status will be recorded on applicable documentation.

Any competent individual may perform the functions of an inspector (see Section A-10).

A-15 CONTROL OF NONCONFORMANCES

Same as document Section 15.

A-16 CORRECTIVE ACTION

Same as document Section 16.

A-17 QUALITY ASSURANCE RECORDS

A-17.1 General

Procedures are established by AREVA NP Inc. to collect and retain records which

provide evidence that design, procurement, fabrication, inspection, testing and field

activities are in accordance with quality requirements. Requirements and

responsibilities for record generation, identification, accumulation, transmittal, retention,

and maintenance are contained in these procedures.

A-18 AUDITS

Audits of a specific project will be done as required by contract or as designated by the

Vice President, Quality & Performance. The following exceptions apply to audits:

• Certification of auditors to audit non-safety related work is not a requirement; however, audits may be performed with the approval of the Manager, Quality Audits and Programs.

• Suppliers for non-safety related applications need not be audited.

Non-safety related suppliers who are audited and certified by other quality organizations

is considered evidence of a quality system, i.e., ISO, DOE, DOD, and ASME.



A-19 NONSAFETY-RELATED SSC’S CREDITED FOR REGULATORY EVENTS

The following criteria applies to fire protection (10 CFR 50.48), anticipated transients

without scram (ATWS) (10 CFR 50.62), the station blackout (SBO) (10 CFR 50.63)

SSC’s that are not safety related.

AREVA NP Inc. implements quality requirements to the fire protection system in

accordance with Regulatory Position 1.7, “Quality Assurance,” in Regulatory Guide

1.189, “Fire Protection for Operating Nuclear Power Plants.”

AREVA NP Inc. implements quality requirements to ATWS equipment in accordance

with Generic Letter 85-06, “Quality Assurance Guidance for ATWS Equipment that is

not Safety Related.”

AREVA NP Inc. implements quality requirements to SBO equipment in accordance with

Regulatory Position 3.5, “Quality Assurance and Specific Guidance for SBO Equipment

that is not Safety-Related,” and Appendix A, “Quality Assurance Guidance for Non-

Safety Systems and Equipment,” in Regulatory Guide 1.155, “Station Blackout.”

ANP-10266, Rev. 3, 'AREVA NP Inc. Quality Assurance Plan ... · AREVA NP Inc. Quality Assurance...

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